S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract
NCT ID: NCT00022633
Last Updated: 2016-08-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
65 participants
INTERVENTIONAL
2001-07-31
2011-07-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gemcitabine, paclitaxel
gemcitabine hydrochloride
paclitaxel
Interventions
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gemcitabine hydrochloride
paclitaxel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Derek Raghavan, MD, PhD, FRACP, FACP
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States
Stormont-Vail Cancer Center
Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Bay Regional Medical Center
Bay City, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States
Metropolitan Hospital
Grand Rapids, Michigan, United States
Holland Community Hospital
Holland, Michigan, United States
Hackley Hospital
Muskegon, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Clinic of Dr. Judy L. Schmidt
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
Finger Lakes Hematology and Oncology
Clifton Springs, New York, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States
Interlakes Oncology/Hematology PC
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Wilson Medical Center
Wilson, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
University Hospital - San Antonio
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Danville Regional Medical Center
Danville, Virginia, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical, PLLC
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Polyclinic First Hill
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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S0028
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068837
Identifier Type: -
Identifier Source: org_study_id
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