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Brief Title: Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy

A Prospective Randomized Phase III Trial of Maintenance Pemetrexed Versus Observation in Patients With Recurrent or Metastatic Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy Without Disease Progression

INTRODUCTION

  • Org Study ID: KCSG GU16-05
  • Secondary ID: N/A
  • NTC ID: NCT03193788
  • Sponsor: Asan Medical Center

BRIEF SUMMARY


This study aims to verify superiority of pemetrexed maintenance to observation for patient
without disease progression after 1 st line cisplatin-based chemotherapy.

DETAILED DESCRIPTION


Patients with unresectable locally advanced, recurrent, or metastatic urothelial carcinoma of
bladder, ureter, or renal pelvis who do not experience disease progression after 4 to 6
cycles of 1 st line chemotherapy administration.

After completion of 4-6 cycles, patients without disease progression on CT which is taken
within 3 weeks after administration of the last chemotherapy will be randomized within 4
weeks after administration of the last chemotherapy to assign either maintenance group or
observation group.

Pemetrexed 500 mg/m 2 mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of
each 21 day cycle, with vitamin supplementation (folic acid 1000μg daily orally from 7 days
prior to treatment initiation and vitamin B12 1000 μg IM 7 days prior to treatment initiation
and then every 3 cycles). Thereafter, vitamin B12 can be injected on the same day of
pemetrexed infusion. Dexamethasone 4 mg orally twice daily for 3 days beginning the day
before treatment to minimize cutaneous reactions.

Treatment continues until occurrence of disease progression or intolerable toxicities upto
maximum of 16 cycles.


  • Overall Status
    Recruiting
  • Start Date
    January 2017
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: progression free survival

Primary Outcome 1 - Timeframe: Every 9 weeks, from date of randomization until the date of first documented progression upto 24 months

CONDITION

  • Bladder Cancer
  • Ureter Cancer
  • Transitional Cell Carcinoma

ELIGIBILITY


Inclusion Criteria:

1. Histologically or cytologically confirmation urothelial cancer of bladder, ureter, or
renal pelvis.

2. Patients must present with locally advanced, recurrent or metastatic disease not
amenable to surgery, radiotherapy, or combined modality therapy with curative intent.

3. Patients who were administered 4-6 cycles of cisplatin-based first line chemotherapy
[GP (gemcitabine/cisplatin), classic MVAC
(methotrexate/vinblastine/doxorubicin/cisplatin), or dose-dense MVAC] and were planned
to undergo regular surveillance

4. ce after confirmation of absence of disease progression on CT taken within 3 week
after the administration of the last cycle of 1st line chemotherapy.

5. For patients with recurrent disease who received prior adjuvant or neoadjuvant
chemotherapy with cisplatin-containing regimen, the last administration of previous
treatment should be administered at least 6 months before start date of 1st line
chemotherapy.

6. Measurable disease according RECIST criteria v 1.1.

7. Age 20 years or older

8. ECOG performance status 2 or better

9. Adequate bone marrow, hepatic, and renal function

10. Signed and dated informed consent of document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment

Exclusion Criteria:

1. Prior systemic chemotherapy or immunotherapy for palliative aim before or after 1st
line cisplatin-based chemotherapy. However, prior intravesical chemotherapy or
immunotherapy is allowed.

2. Disease progression during or after 1st line cisplatin-based chemotherapy

3. Known CNS metastasis

4. Diagnosis of any serious secondary malignancy within the last 2 years, except for
adequately treated basal cell or squamous cell carcinoma of skin, early gastric
carcinoma, early stage thyroid carcinoma, insignificant prostate carcinoma, or in situ
carcinoma of cervix uteri

5. Pregnancy or breast feeding.

6. Serious hypersensitivity reaction to pemetrexed.

7. Severe renal function impairment with creatinine clearance 〈45 mL/min by standard
Cockcroft-Gault formula or GFR measured by Tc99m-DPTA serum clearance method.

8. Other severe acute or chronic medical or psychiatric condition

Gender: All

Minimum Age: N/A

Maximum Age: 20 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jae-Lyun Lee, MD, PhD

Role: Principal Investigator

Affiliation: Asan Medical Center

Overall Contact

Name: Jae-Lyun Lee, MD, PhD

Phone: 82 2 3010 5977

Email: jaelyun@amc.seoul.kr

LOCATION

Facility Status Contact
Facility: Hallym University Medical Center, Hallym University College of Medicine
Anyang,
Korea, Republic of
Status: Recruiting Contact:
Ho Young Kim

ksfam@daum.net
Facility: Keimyeong University Dongsan Medical Center
Daegu, 700-712
Korea, Republic of
Status: Recruiting Contact:
Jin Young Kim, MD

takgu@dsmc.or.kr
Facility: Fatima Hospital
Daegu,
Korea, Republic of
Status: Recruiting Contact:
Jung Lim Lee

junglim3@gmail.com
Facility: Chungnam University Hospital
Daejeon, 301-721
Korea, Republic of
Status: Recruiting Contact:
Hyo Jin Lee, MD, PhD.

cymed@cnu.ac.kr
Facility: National Health Insurance Service Ilsan Hospital
Goyang,
Korea, Republic of
Status: Recruiting Contact:
Soo Jung Hong

suzzy901@nhimc.or.kr
Facility: Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si,
Korea, Republic of
Status: Recruiting Contact:
Hyun Ae Jung

hyunaejung@hallym.or.kr
Facility: Gil Medical Center
Incheon, 21565
Korea, Republic of
Status: Recruiting Contact:
Inkeun Park, MD

ingni79@hanmail.net
Facility: Dong-A University Medical Center
Pusan,
Korea, Republic of
Status: Recruiting Contact:
Suee Lee

Facility: Inje University Haeundae Paik Hospital
Pusan,
Korea, Republic of
Status: Recruiting Contact:
Il-Hwan Kim

onelement@daum.net
Facility: Pusan National University Hospital, Pusan National University School of Medicine
Pusan,
Korea, Republic of
Status: Recruiting Contact:
Hyo Jung Kim

leonkim80@naver.com
Facility: Asan Medical Center
Seoul, 138-736
Korea, Republic of
Status: Recruiting Contact:
Jae-Lyun Lee, MD, PhD
82 2 3010 5977
jaelyun@amc.seoul.kr
Facility: Chung Ang University Hospital
Seoul, 156-755
Korea, Republic of
Status: Recruiting Contact:
Hee Joon Kim, MD

heejun.dino11@gmail.com
Facility: Inje University Sanggye Paik Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Byeong Seok Sohn

imbs@paik.ac.kr
Facility: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Yun-Gyoo Lee

gosciny@gmail.com
Facility: Korea University Anam Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Yoon Ji Choi

yoonji23@hanmail.net
Facility: Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Bhum Suk Keam

Facility: Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul,
Korea, Republic of
Status: Recruiting Contact:
In-Ho Kim

ihkmd@naver.com
Facility: Yonsei Cancer Center
Seoul,
Korea, Republic of
Status: Recruiting Contact:
Sang Joon Shin

ssj338@yuhs.ac
Facility: St. Vincent's Hospital, The Catholic University of Korea
Suwon,
Korea, Republic of
Status: Recruiting Contact:
Byoung Yong Shim

shimby@catholic.ac.kr
Facility: Uijeongbu St Mary's hospital, Catholic university of Korea
Uijeongbu,
Korea, Republic of
Status: Recruiting Contact:
Yoon Ho Ko

koyoonho@catholic.ac.kr
Facility: Pusan National University Yangsan Hospital
Yangsan,
Korea, Republic of
Status: Recruiting Contact:
Kwonoh Park

parkkoh@hanmail.net