Combination Chemotherapy in Treating Patients With Bladder Cancer

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients who have advanced bladder cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma of the bladder

• Any T, N+, M0 OR

• T3a-4a, N0, M0

• At least 6 weeks but no more than 3 months since prior complete resection of bladder

• Cystoprostatectomy plus pelvic lymph node dissection in males

• Cystectomy/total abdominal hysterectomy/bilateral salpingo-oophorectomy plus pelvic lymph node dissection in females

• Negative surgical margins

• Carcinoma in situ allowed

• No partial cystectomy or transurethral bladder tumor resection as definitive loco-regional therapy

• Prostate cancer detected in resected specimen allowed if post-operative PSA is no more than 0.05 mg/dL

• No metastatic or recurrent disease by post-operative chest x-ray and CT scan of abdomen and pelvis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Hematopoietic:

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 150,000/mm^3

Hepatic:

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2 times ULN

• AST ≤ 2 times ULN

Renal:

• Creatinine ≤ 1.5 mg/dL OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular:

• Normal cardiac function by history, physical exam, or chest radiograph

• Left ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram, for prior cardiac disease

• No New York Heart Association class III or IV heart disease

• No serious cardiac arrhythmias including first-, second-, and third-degree heart block

Other:

• Negative pregnancy test

• No uncontrolled infection

• No other active cancer within the past 5 years except non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to bladder