S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the U… (NCT00022633) | Clinical Trial Compass
TerminatedPhase 2
S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract
Stopped: Permanently Closed Due to Poor Accrual
United States65 participantsStarted 2001-07
Plain-language 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.
Who can participate
Age range120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-…
What they're measuring
1
Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
Timeframe: 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)