Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium

Phase 2

Completed

• Conditions: Urethral Cancer; Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter
• Interventions: Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

• Registration Number: NCT00053209
• Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.

Detailed Description

OBJECTIVES:

Primary

* Determine the response rate in patients with previously untreated advanced cancer of the urothelium treated with pemetrexed disodium and gemcitabine.

* Determine the toxicity of this regimen in these patients.

Secondary

* Determine the overall survival and time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive cyanocobalamin intramuscularly once every 9 weeks and folic acid orally once daily beginning on day -6 and continuing until 3 weeks after the completion of study therapy. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 24-46 patients will be accrued for this study within 15 -18 months.

Study Timeline

• Study First Submitted: 2003-01-27
• Study First Submitted QC: 2003-01-27
• Study First Posted: 2003-01-28
• Study Start: 2004-08-10
• Primary Completion: 2007-09
• Study Completion: 2009-05
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pemetrexed Disodium and Gemcitabine	pemetrexed disodium	Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles
Pemetrexed Disodium and Gemcitabine	gemcitabine hydrochloride	Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles

Primary Outcome Measures

Name	Time	Method
Response as measured by RECIST criteria	Assessed every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Time to disease progression	Assessed every 6 weeks
Overall survival	Assessed every 3 months for 2 years, then every 6 months for 3 years

Trial Locations

Locations (121)

Aurora Presbyterian Hospital; 🇺🇸 Aurora, Colorado, United States

Boulder Community Hospital; 🇺🇸 Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital; 🇺🇸 Colorado Springs, Colorado, United States

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center; 🇺🇸 Denver, Colorado, United States

St. Joseph Hospital; 🇺🇸 Denver, Colorado, United States

Rose Medical Center; 🇺🇸 Denver, Colorado, United States

CCOP - Colorado Cancer Research Program, Incorporated; 🇺🇸 Denver, Colorado, United States

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

Sky Ridge Medical Center; 🇺🇸 Lone Tree, Colorado, United States

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