Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium.

PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Carboplatin; Gemcitabine; Methotrexate; Vinblastine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell cancer of the urothelium, including the renal pelvis, ureters, urinary bladder, and urethra, meeting 1 of the following criteria:

• Unresected positive lymph node

• Distant metastases (M1, stage IV)

• Unresectable primary bladder cancer (T3-4)

• Measurable disease

• Ineligible for cisplatin-based chemotherapy and presenting with the following:

• WHO performance status 2 AND/OR

• Glomerular filtration rate greater than 30 mL/min but less than 60 mL/min

• No brain metastases or other CNS lesions

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• See Disease Characteristics

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3

• Platelet count at least 125,000/mm^3

Hepatic:

• Bilirubin no greater than 1.25 times normal

• AST/ALT no greater than 3 times normal (5 times normal if liver metastases are present)

Renal:

• See Disease Characteristics

• Calcium normal

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 6 months after study participation

• No psychological, familial, sociological, or geographical condition that would preclude study participation

• No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior systemic biologic therapy

Chemotherapy:

• See Disease Characteristics

• No prior systemic cytotoxic therapy (including adjuvant and neoadjuvant chemotherapy)

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 months since prior radiotherapy

• Prior radiotherapy to study lesions allowed if there is evidence of disease progression

Surgery:

• Not specified