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Brief Title: Comparing the New Anti-cancer Drug Eribulin With or Without Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer

A Phase III Randomized Trial of Eribulin (NSC #707389) With or Without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

INTRODUCTION

  • Org Study ID: NCI-2020-07651
  • Secondary ID: NCI-2020-07651, S1937, S1937, U10CA180888
  • NTC ID: NCT04579224
  • Sponsor: National Cancer Institute (NCI)

BRIEF SUMMARY

This phase III trial compares the usual chemotherapy treatment to eribulin alone and to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.

DETAILED DESCRIPTION

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin mesylate (eribulin) alone.

II. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin plus gemcitabine hydrochloride (gemcitabine).

III. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to eribulin alone versus eribulin plus gemcitabine.

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) in the standard treatment arm to the two experimental treatment arms in this population.

II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR), both confirmed and unconfirmed, complete and partial responses (CR and PR), in the standard treatment arm to the two experimental treatment arms in the subset of participants with measurable disease in this population.

III. To compare duration of response (DOR) in the standard treatment arm to the two experimental treatment arms in the subset of participants with measurable disease in this population.

IV. To compare disease control rate (DCR) in the standard treatment arm to the two experimental treatment arms in the subset of participants with measurable disease in this population.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive 1 of the 3 standard of care chemotherapy regimens based on treating investigator's choice: Choice A: Patients receive docetaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice B: Patients receive gemcitabine IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Choice C: Patients receive paclitaxel IV on days 1, 8, and 15. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive eribulin IV over 2-5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years from the date of registration, then every 12 months until death or 3 years from the date of registration

  • Overall Status
    Recruiting
  • Start Date
    February 16, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall survival

Primary Outcome 1 - Timeframe: From date of registration to date of death due to any cause, assessed up to 3 years

CONDITION

  • Metastatic Bladder Urothelial Carcinoma
  • Metastatic Renal Pelvis Urothelial Carcinoma
  • Metastatic Ureter Urothelial Carcinoma
  • Metastatic Urethral Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Refractory Bladder Urothelial Carcinoma
  • Refractory Renal Pelvis Urothelial Carcinoma
  • Refractory Ureter Urothelial Carcinoma
  • Refractory Urethral Urothelial Carcinoma
  • Refractory Urothelial Carcinoma
  • Stage IV Bladder Cancer AJCC v8
  • Stage IV Renal Pelvis and Ureter Cancer AJCC v8
  • Stage IV Renal Pelvis Cancer AJCC v8
  • Stage IV Ureter Cancer AJCC v8
  • Stage IV Urethral Cancer AJCC v8
  • Stage IVA Bladder Cancer AJCC v8
  • Stage IVB Bladder Cancer AJCC v8

ELIGIBILITY

Inclusion Criteria:
Participant must have predominant histologically and cytologically proven urothelial carcinoma in a metastatic site

- Participant must have evidence of metastatic urothelial carcinoma based on computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration

- Participant must have had progression of disease following prior therapy at the discretion of the treating investigator
Participant must have received previous systemic treatment for metastatic urothelial carcinoma with either a platinum-based chemotherapy regimen, systemic PD1/PDL1 immunotherapy, an antibody drug conjugate such as, enfortumab vedotin or sacituzumab govitecan (through standard of care or a clinical trial). There is no limit to the number of prior regimens patient may have received for urothelial carcinoma
If participant is a candidate for a platinum-based chemotherapy, then participant must have previously received a platinum-based chemotherapy

- If participant is a candidate for immunotherapy, then participant must have previously received immunotherapy. If participant is not a candidate for immunotherapy, then participant either: (a) must have had prior anti PD1/PDL1 antibody therapy; OR (b) must have not been a candidate for anti PD1/PDL1 antibody therapy in the opinion of the treating physician

- Participant is eligible if platinum based chemotherapy and/or anti PDL/PDL1 antibody therapy was provided in perioperative setting before or after radical cystectomy and if there is evidence of progression to metastatic disease within 12 months of the last dose of therapy. For instance, a patient treated with dose-dense combination of methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in neoadjuvant setting, then radical cystectomy followed by adjuvant pembrolizumab on AMBASSADOR trial will meet the requirement for prior/concurrent therapy if progression of disease occurs within 12 months of discontinuation of pembrolizumab

- Participant must have received any planned surgery prior to registration

- Participant must have Zubrod performance status 0-2

- Participant must have history and physical examination within 28 days prior to registration

- Participant must have complete blood count (CBC), complete metabolic panel including liver function tests, and lactate dehydrogenase (LDH) obtained with 28 days prior to registration

- Participant must have adequate kidney function as evidenced by measured or calculated creatinine clearance >= 50 mL/min within 28 days prior to registration

- Participant must have adequate hepatic function documented by either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (IULN) within 28 days prior to registration. If both AST and ALT are performed, both must be =< 3 x IULN. For participants with liver metastases, AST or ALT must be =< 5 x IULN - Participant must be on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration if they are known to have human immunodeficiency virus (HIV)-infection - Participants must have undetectable hepatitis B virus (HBV) viral load within 28 days prior to registration if participant has known chronic hepatitis B virus (HBV) infection - Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load within 28 days prior to registration - Participants may have a prior or concurrent malignancy provided the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per the opinion of the treating investigator - Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria:
Participants must not require immediate central nervous system (CNS)-specific treatment, in the opinion of the treating investigator if they have active brain metastases (defined as new or progressive brain metastases) or leptomeningeal disease

- Participant must not have progressed within 3 months following last dose of gemcitabine

- Participant must not have unresolved toxicities from prior surgeries or radiation therapy > grade 1 at the time of registration to registration

- Participants must not be planning to take strong or moderate CYP3A or CYP2C8 inhibitors or inducers if randomized to Arm 1 and standard of care (SOC) regimen chosen is paclitaxel or docetaxel. Participants receiving strong or moderate CYP3A or CYP2C8 inducers must discontinue use at least 2 weeks prior to randomization

- Participant must not have a known history of corrected QT (QTc) prolongation

- Participants must not be pregnant or nursing due to the risk of harm to a fetus or nursing infant. Women and men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study and 6 months (females) or 3.5 months (males) after the last dose. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sarmad Sadeghi

Role: Principal Investigator

Affiliation: Southwest Oncology Group

Overall Contact

Name: Sarmad Sadeghi

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: PCR Oncology
Arroyo Grande, California 93420
United States
Status: Recruiting Contact: Principal Investigator
Sarmad Sadeghi
719-776-6550
stephanie.couch@stjoeshealth.org
Facility: Los Angeles County-USC Medical Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Site Public Contact
719-776-6550
mccinfo@mtcancer.org
Facility: USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Principal Investigator
Sarmad Sadeghi
954-267-7748
mccinfo@mtcancer.org
Facility: USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California 92663
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
mccinfo@mtcancer.org
Facility: Porter Adventist Hospital
Denver, Colorado 80210
United States
Status: Recruiting Contact: Contact
Site Public Contact
309-243-3605
morganthaler.jodi@mhsil.com
Facility: Littleton Adventist Hospital
Littleton, Colorado 80122
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
andersonj@illinoiscancercare.com
Facility: Parker Adventist Hospital
Parker, Colorado 80138
United States
Status: Recruiting Contact: Principal Investigator
John M. Schallenkamp
800-446-5532
andersonj@illinoiscancercare.com
Facility: Holy Cross Hospital
Fort Lauderdale, Florida 33308
United States
Status: Recruiting Contact: Contact
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Facility: Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Status: Recruiting Contact: Contact
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Facility: Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Status: Recruiting Contact: Principal Investigator
John M. Schallenkamp
800-446-5532
andersonj@illinoiscancercare.com
Facility: Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Status: Recruiting Contact: Contact
Site Public Contact
708-226-4357
andersonj@illinoiscancercare.com
Facility: Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
309-243-3605
clinical.trials@daytonncorp.org
Facility: Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Status: Recruiting Contact: Contact
Site Public Contact
309-243-3605
ksoder@mcfarlandclinic.com
Facility: Kootenai Cancer Clinic
Sandpoint, Idaho 83864
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
309-243-3605
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-444-7541
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Canton
Canton, Illinois 61520
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
800-446-5532
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Carthage
Carthage, Illinois 62321
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132
CTOResearch@hfhs.org
Facility: Carle on Vermilion
Danville, Illinois 61832
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132
stephanie.couch@stjoeshealth.org
Facility: Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Principal Investigator
Prem Sobti
515-282-2921
stephanie.couch@stjoeshealth.org
Facility: Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-282-2200
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Dixon
Dixon, Illinois 61021
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
515-956-4132
stephanie.couch@stjoeshealth.org
Facility: Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132
stephanie.couch@stjoeshealth.org
Facility: Crossroads Cancer Center
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
515-956-4132
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Eureka
Eureka, Illinois 61530
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Loyola University Medical Center
Maywood, Illinois 60153
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United States
Status: Recruiting Contact: Principal Investigator
Stephanie A. Berg
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Pekin
Pekin, Illinois 61554
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Peoria
Peoria, Illinois 61615
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Peru
Peru, Illinois 61354
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Illinois CancerCare-Princeton
Princeton, Illinois 61356
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Springfield Clinic
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Carle Cancer Center
Urbana, Illinois 61801
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
sfmc@sfmc.net
Facility: Illinois CancerCare - Washington
Washington, Illinois 61571
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
mccinfo@mtcancer.org
Facility: Reid Health
Richmond, Indiana 47374
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
mccinfo@mtcancer.org
Facility: Mary Greeley Medical Center
Ames, Iowa 50010
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
mccinfo@mtcancer.org
Facility: McFarland Clinic PC - Ames
Ames, Iowa 50010
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
mccinfo@mtcancer.org
Facility: McFarland Clinic PC-Boone
Boone, Iowa 50036
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
mccinfo@mtcancer.org
Facility: Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
OncologyClinicalTrialsFargo@sanfordhealth.org
Facility: Broadlawns Medical Center
Des Moines, Iowa 50314
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org
Facility: McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa 50501
United States
Status: Recruiting Contact: Principal Investigator
Debra M. Prow
314-996-5569
clinical.trials@daytonncorp.org
Facility: McFarland Clinic PC-Jefferson
Jefferson, Iowa 50129
United States
Status: Recruiting Contact: Principal Investigator
Joshua Lukenbill
314-996-5569
clinical.trials@daytonncorp.org
Facility: McFarland Clinic PC-Marshalltown
Marshalltown, Iowa 50158
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569
clinical.trials@daytonncorp.org
Facility: Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Status: Recruiting Contact: Contact
Site Public Contact
910-587-9084
clinicaltrials@sfmc-gi.org
Facility: IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
701-323-5760
mmcorc@healthpartners.com
Facility: Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Contact
Site Public Contact
701-323-5760
Facility: IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Contact
Site Public Contact
937-528-2900
Facility: Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
937-528-2900
Facility: IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
937-528-2900
Facility: Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Contact
Site Public Contact
937-528-2900
Facility: Henry Ford Hospital
Detroit, Michigan 48202
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
937-528-2900
Facility: Ascension Saint John Hospital
Detroit, Michigan 48236
United States
Status: Recruiting Contact: Contact
Site Public Contact
405-271-8777
Facility: Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
406-969-6060
Facility: Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
Facility: Genesee Hematology Oncology PC
Flint, Michigan 48503
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
734-712-3671
Facility: Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
605-312-3320
Facility: Hurley Medical Center
Flint, Michigan 48503
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
605-312-3320
Facility: Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan 48236
United States
Status: Recruiting Contact: Contact
Site Public Contact
423-578-8538
Facility: Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds
423-578-8538
Facility: Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan 48236
United States
Status: Recruiting Contact: Contact
Site Public Contact
423-578-8538
Facility: Hope Cancer Clinic
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: Saint Mary Mercy Hospital
Livonia, Michigan 48154
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: Michigan Breast Specialists-Macomb Township
Macomb, Michigan 48044
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: Advanced Breast Care Center PLLC
Warren, Michigan 48088
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: Michigan Breast Specialists-Warren
Warren, Michigan 48093
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Huron Gastroenterology PC
Ypsilanti, Michigan 48106
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Status: Recruiting Contact: Principal Investigator
Christopher M. Reynolds

Facility: University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller

Facility: Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Parkland Health Center - Farmington
Farmington, Missouri 63640
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United States
Status: Recruiting Contact: Principal Investigator
John A. Ellerton

Facility: Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Status: Recruiting Contact: Principal Investigator
John A. Ellerton

Facility: Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
United States
Status: Recruiting Contact: Principal Investigator
John P. Stoutenburg

Facility: Community Hospital of Anaconda
Anaconda, Montana 59711
United States
Status: Recruiting Contact: Principal Investigator
Samer S. Kasbari

Facility: Billings Clinic Cancer Center
Billings, Montana 59101
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Bozeman Deaconess Hospital
Bozeman, Montana 59715
United States
Status: Recruiting Contact: Principal Investigator
Samer S. Kasbari

Facility: Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Kalispell Regional Medical Center
Kalispell, Montana 59901
United States
Status: Recruiting Contact: Contact
Site Public Contact

Facility: Community Medical Hospital
Missoula, Montana 59804
United States
Status: Recruiting Contact: Principal Investigator
Preston D. Steen

Facility: OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
United States
Status: Recruiting Contact: Principal Investigator
Howard M. Gross

Facility: OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
United States
Status: Recruiting Contact: N/A
Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Status: Recruiting Contact: N/A
Facility: Glens Falls Hospital
Glens Falls, New York 12801
United States
Status: Recruiting Contact: N/A
Facility: Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
United States
Status: Recruiting Contact: N/A
Facility: Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
United States
Status: Recruiting Contact: N/A
Facility: Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
United States
Status: Recruiting Contact: N/A
Facility: Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Status: Recruiting Contact: N/A
Facility: Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Status: Recruiting Contact: N/A
Facility: Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
Status: Recruiting Contact: N/A
Facility: Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
United States
Status: Recruiting Contact: N/A
Facility: Miami Valley Hospital South
Centerville, Ohio 45459
United States
Status: Recruiting Contact: N/A
Facility: Miami Valley Hospital
Dayton, Ohio 45409
United States
Status: Recruiting Contact: N/A
Facility: Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
United States
Status: Recruiting Contact: N/A
Facility: Miami Valley Hospital North
Dayton, Ohio 45415
United States
Status: Recruiting Contact: N/A
Facility: Armes Family Cancer Center
Findlay, Ohio 45840
United States
Status: Recruiting Contact: N/A
Facility: Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
United States
Status: Recruiting Contact: N/A
Facility: Greater Dayton Cancer Center
Kettering, Ohio 45409
United States
Status: Recruiting Contact: N/A
Facility: Kettering Medical Center
Kettering, Ohio 45429
United States
Status: Recruiting Contact: N/A
Facility: Springfield Regional Cancer Center
Springfield, Ohio 45504
United States
Status: Recruiting Contact: N/A
Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: N/A
Facility: Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
United States
Status: Recruiting Contact: N/A
Facility: Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
United States
Status: Recruiting Contact: N/A
Facility: Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
United States
Status: Recruiting Contact: N/A
Facility: Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Status: Recruiting Contact: N/A
Facility: Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
Status: Recruiting Contact: N/A
Facility: Regional Cancer Center at Indian Path Community Hospital
Kingsport, Tennessee 37660
United States
Status: Recruiting Contact: N/A
Facility: Wellmont Medical Associates-Bristol
Bristol, Virginia 24201
United States
Status: Recruiting Contact: N/A
Facility: Southwest VA Regional Cancer Center
Norton, Virginia 24273
United States
Status: Recruiting Contact: N/A
Facility: Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington 98310
United States
Status: Recruiting Contact: N/A
Facility: Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
United States
Status: Recruiting Contact: N/A