S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, recurrent urethral cancer, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter
Eligibility 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
Sites / Locations
- Mobile Infirmary Medical Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- USC/Norris Comprehensive Cancer Center and Hospital
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Regional Cancer Center at Memorial Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Stormont-Vail Cancer Center
- St. Francis Comprehensive Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metropolitan Hospital
- Holland Community Hospital
- Hackley Hospital
- Mercy Regional Cancer Center at Mercy Hospital
- Munson Medical Center
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Big Sky Oncology
- Sletten Regional Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Clinic of Dr. Judy L. Schmidt
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Finger Lakes Hematology and Oncology
- Tucker Center for Cancer Care at Orange Regional Medical Center
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilson Medical Center
- McDowell Cancer Center at Akron General Medical Center
- Cleveland Clinic Taussig Cancer Center
- Community Oncology Group at Cleveland Clinic Cancer Center
- Cleveland Clinic - Wooster
- AnMed Health Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Medical City Dallas Hospital
- Brooke Army Medical Center
- Wilford Hall Medical Center
- Veterans Affairs Medical Center - San Antonio (Murphy)
- University of Texas Health Science Center at San Antonio
- Cancer Therapy and Research Center
- University Hospital - San Antonio
- CCOP - Scott and White Hospital
- Danville Regional Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Skagit Valley Hospital Cancer Care Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Wenatchee Valley Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
gemcitabine, paclitaxel