Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

• Status: Completed
• Trial end date: 2004-10-01
• 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer.

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

Details

• Lead Sponsor: Tulane University Health Sciences Center
• Treatments: Carboplatin; Gemcitabine; Ifosfamide; Paclitaxel

Criteria

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 Characteristics

Other:

• No other concurrent investigational therapy