NCT00014534
Combination Chemotherapy in Treating Patients With Bladder Cancer
PHASE3
COMPLETED
NCT00014534
INTERVENTIONAL
Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder
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.
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
Bladder Cancer
- TREATMENT
-
- Type: BIOLOGICAL
- Name: filgrastim
- Description: 6 mg sub Q
- Arm Group Labels: Gemcitabine + Doxorubicin + Pegfilgrastim
-
- Type: DRUG
- Name: cisplatin
- Description: 60 mg/sq m IV
- Arm Group Labels: Gemcitabine + cisplatin
-
- Type: DRUG
- Name: doxorubicin hydrochloride
- Description: 50 mg/ sq m IV
- Arm Group Labels: Gemcitabine + Doxorubicin + Pegfilgrastim
-
- Type: DRUG
- Name: gemcitabine hydrochloride
- Description: 1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm
- Arm Group Labels: Gemcitabine + Doxorubicin + Pegfilgrastim, Gemcitabine + cisplatin
- Alliance for Clinical Trials in Oncology