S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract

• Status: Terminated
• Trial end date: 2011-07-01
• 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. Giving more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent cancer of the urinary tract.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed urothelial cancer

• Transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder, renal pelvis, ureter, or urethra)

• Previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes) disease OR

• Locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible for further radiotherapy or surgery

• Measurable disease

PATIENT CHARACTERISTICS:

Age:

• 70 and over OR

• Under 60

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 1,200/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• Aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) no greater than 2 times ULN

Renal:

• Creatinine no greater than ULN

Other:

• HIV negative

• No other concurrent life-threatening medical disorder that would preclude study participation

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior adjuvant chemotherapy is allowed provided administered more than 10 years ago

• No prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 28 days since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics

• At least 28 days since prior surgery and recovered