Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer (NCT00028860) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer
United StatesStarted 2001-10
Plain-language 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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer.
Who can participate
SexALL
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DISEASE CHARACTERISTICS:
* Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter, and renal pelvis
* T3b-4, N0, M0 OR
* Any T, N1-3, M0
* Cystectomy within the past 8 weeks
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* ECOG 0-1
Life expectancy:
* At least 12 months
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST or ALT no greater than 2.5 times ULN
Renal:
* Creatinine no greater than ULN
* Albumin no greater than ULN
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer
* No active serious infection, other serious underlying medical condition, dementia, or significantly altered mental status that would preclude study participation
* No known hypersensitivity to Cremophor EL
* No pre-existing clinically significant grade 2 or greater neuropathy
* No AIDS (HIV positivity alone allowed)
* No known hypersensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for malignancy
* No neoadjuvant chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for malignancy
Surgery:
* See Disease C…