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Phase II-III Chemotherapy with CAP (CTX/ADR/CACP) vs AMSA for Advanced Transitional Cell Cancer of the Urinary Bladder (Summary Last Modified 06/97)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III, Phase II

Treatment

Completed

no age specified

NCI

SWOG-7922

Objectives

I.  Compare effects of CAP:  cyclophosphamide/adriamycin/cis-platinum vs. AMSA 
for patients with good renal function who have advanced, transitional cell 
carcinoma of the urinary bladder and have failed on previous surgery and/or 
radiotherapy.
II.  Determine response rate to alternate treatment arm following cross-over 
of patients failing initial therapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed, measurable, Stage IV transitional cell carcinoma of the urinary 
bladder who have failed on previous surgery and/or radiotherapy.  Patients 
must have life expectancy of at least 8 weeks, good renal function, at least 1 
functioning kidney, and adequate hematologic and liver function.  Patients 
must not have received prior systemic chemotherapy.

Expected Enrollment

40 patients per year will be entered.  Protocol closed September 1982 with 
sufficient accrual to meet objectives.

Outline

Randomized study.
Arm I:  3-Drug Combination Chemotherapy.  CAP:  Cyclophosphamide, CTX, 
NSC-26271; Adriamycin, ADR, NSC-123127; cis-Platinum, CACP, NSC-119875.
Arm II:  Single-agent Chemotherapy.  m-AMSA, AMSA, NSC-249992.

Published Results

Al-Sarraf M, Frank J, Smith JA Jr, et al.: Phase II trial of cyclophosphamide, doxorubicin, and cisplatin (CAP) versus amsacrine in patients with transitional cell carcinoma of the urinary bladder: a Southwest Oncology Group study. Cancer Treat Rep 69 (2): 189-94, 1985.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Coltman, MD, Protocol chair(Contact information may not be current)
Ph: 210-567-2710

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.