Overview

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