Bladder Cancer Clinical Trial

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

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.

View Full Description

Full Description

OBJECTIVES:

Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study.
Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective response rate and 2-year survival, in these elderly patients.
Assess the toxicity and tolerability of this regimen in these elderly patients.
Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in these patients.
Determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years.

OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs under 60).

Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80 patients (60 age 70 and over and 20 under age 60) will be accrued for this study.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

65

Study ID:

NCT00022633

Recruitment Status:

Terminated

Sponsor:

Southwest Oncology Group

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There are 73 Locations for this study

See Locations Near You

Mobile Infirmary Medical Center
Mobile Alabama, 36652, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta Georgia, 31603, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina Kansas, 67401, United States
Stormont-Vail Cancer Center
Topeka Kansas, 66604, United States
St. Francis Comprehensive Cancer Center
Topeka Kansas, 66606, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Bay Regional Medical Center
Bay City Michigan, 48708, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids Michigan, 49503, United States
Metropolitan Hospital
Grand Rapids Michigan, 49506, United States
Holland Community Hospital
Holland Michigan, 49423, United States
Hackley Hospital
Muskegon Michigan, 49443, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare
Billings Montana, 59101, United States
Deaconess Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
St. James Community Hospital
Butte Montana, 59701, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Clinic of Dr. Judy L. Schmidt
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney Nebraska, 68848, United States
Finger Lakes Hematology and Oncology
Clifton Springs New York, 14432, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown New York, 10940, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence Ohio, 44131, United States
Cleveland Clinic - Wooster
Wooster Ohio, 44691, United States
AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Wilford Hall Medical Center
Lackland AFB Texas, 78236, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78209, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Cancer Therapy and Research Center
San Antonio Texas, 78229, United States
University Hospital - San Antonio
San Antonio Texas, 78229, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
St. Joseph Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Skagit Valley Hospital Cancer Care Center
Mt. Vernon Washington, 98273, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98104, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical, PLLC
Seattle Washington, 98104, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Polyclinic First Hill
Seattle Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
North Puget Oncology at United General Hospital
Sedro-Wooley Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Wenatchee Valley Medical Center
Wenatchee Washington, 98801, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

65

Study ID:

NCT00022633

Recruitment Status:

Terminated

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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