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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
  • NCT 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
    Unknown status
  • Start Date
    January, 2017
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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: 20 Years

Maximum Age: N/A

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, MiRan Kim

Phone: 82 2 3010 5977, 82 2 3010 5576

Email: jaelyun@amc.seoul.kr, crnonc12@amc.seoul.kr

LOCATION

Facility Status Contact

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