Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00022633

Purpose

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.

Condition	Intervention	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer	Drug: gemcitabine hydrochloride Drug: paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years)

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Paclitaxel Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Study treatment feasibility [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate (confirmed and unconfirmed complete and partial response) [ Designated as safety issue: No ]
Survival at 2 years [ Designated as safety issue: No ]
Toxicity and tolerability [ Designated as safety issue: Yes ]
Feasibility of standardized self-report measures of comorbidity, depression, and functional status [ Designated as safety issue: No ]
Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	July 2001

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)
SGOT or 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022633

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Locations

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Georgia
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States, 31603
United States, Illinois
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Stormont-Vail Cancer Center
Topeka, Kansas, United States, 66604
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
CCOP - Wichita
Wichita, Kansas, United States, 67214
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Southwest Medical Center
Liberal, Kansas, United States, 67901
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Hackley Hospital
Muskegon, Michigan, United States, 49443
Munson Medical Center
Traverse City, Michigan, United States, 49684
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Metropolitan Hospital
Grand Rapids, Michigan, United States, 49506
Holland Community Hospital
Holland, Michigan, United States, 49423
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States, 49503
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Clinic of Dr. Judy L. Schmidt
Missoula, Montana, United States, 59804
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
United States, New York
Finger Lakes Hematology and Oncology
Clifton Springs, New York, United States, 14432
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States, 10940-4199
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, Ohio
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
University Hospital - San Antonio
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78209
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Polyclinic First Hill
Seattle, Washington, United States, 98122
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Derek Raghavan, MD, PhD, FRACP, FACP	The Cleveland Clinic
Investigator:	Maha Hadi A. Hussain, MD	University of Michigan Cancer Center

Study ID Numbers:	CDR0000068837, SWOG-S0028
Study First Received:	August 10, 2001
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00022633 History of Changes
Health Authority:	United States: Federal Government