S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin

Phase 2

Completed

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder may kill more tumor cells.

PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).

Detailed Description: OBJECTIVES:

* Determine the 8-12 week efficacy of intravesical gemcitabine, in terms of complete response rate, in patients with recurrent superficial transitional cell carcinoma of the bladder that have progressed despite prior intravesical Bacillus Calmette-Guerin (BCG).

* Determine the recurrence-free, worsening-free, progression-free, and overall survival of patients treated with this drug.

* Evaluate the toxicity of this drug in these patients.

* Correlate, preliminarily, expression levels of genes or genetic polymorphisms involved in the gemcitabine pathway and angiogenesis with clinical toxicity, response, and relapse-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive gemcitabine intravesically once a week for 6 weeks (weeks 1-6) in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response proceed to maintenance therapy at week 14.

* Maintenance therapy: Patients receive gemcitabine intravesically once in weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 6-12 months.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Intravesical Gemcitabine	gemcitabine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Complete Response Rate at the End of Induction	Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5	Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Overall Survival (OS)	1 year	Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.
Recurrence-free Survival (RFS)	1 year	Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.

Locations (97): Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Cancer Centers of Central Florida, PA
🇺🇸
Leesburg, Florida, United States
Kapiolani Medical Center at Pali Momi
🇺🇸
Aiea, Hawaii, United States
Cancer Research Center of Hawaii
🇺🇸
Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸
Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸
Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
🇺🇸
Honolulu, Hawaii, United States
Hawaii Medical Center - East
🇺🇸
Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸
Honolulu, Hawaii, United States
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States