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

Phase 2

Terminated

Conditions: Transitional Cell Cancer of the Renal Pelvis and Ureter
Bladder Cancer
Urethral Cancer

Interventions: Drug: gemcitabine hydrochloride
Drug: paclitaxel

Registration Number: NCT00022633

Lead Sponsor: SWOG Cancer Research Network

Brief 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gemcitabine, paclitaxel	gemcitabine hydrochloride	-
gemcitabine, paclitaxel	paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols	66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)	Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival in Patients Aged 70 Years and Older	0-5 years	Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.
Overall Survival (OS) in Patients Aged 70 Years and Older	0-5 years	Measured from date of registration to date of death due to any cause.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms	at study entry (prior to administration of any treatment)	Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required	at study entry (prior to administration of any treatment)	Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)	every week for the first 4 weeks and then every 3 weeks for up to 19 weeks	Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate	at study entry (prior to administration of any treatment)	Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

Trial Locations

Locations (92): Mobile Infirmary Medical Center
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Mobile, Alabama, United States
Holland Community Hospital
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Holland, Michigan, United States
Munson Medical Center
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Traverse City, Michigan, United States
St. James Community Hospital
🇺🇸
Butte, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare
🇺🇸
Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸
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
McDowell Cancer Center at Akron General Medical Center
🇺🇸
Akron, Ohio, United States
AnMed Health Cancer Center
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Anderson, South Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸
Cleveland, Ohio, United States
CCOP - Upstate Carolina
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Spartanburg, South Carolina, United States
Harborview Medical Center
🇺🇸
Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸
Seattle, Washington, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸
Springfield, Illinois, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸
Valdosta, Georgia, United States
CCOP - Wichita
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Wichita, Kansas, United States
Bay Regional Medical Center
🇺🇸
Bay City, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
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Battle Creek, Michigan, United States
Mecosta County Medical Center
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Big Rapids, Michigan, United States
CCOP - Grand Rapids
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Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
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Grand Rapids, Michigan, United States
Spectrum Health Hospital - Butterworth Campus
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Grand Rapids, Michigan, United States
Metropolitan Hospital
🇺🇸
Grand Rapids, Michigan, United States
Hackley Hospital
🇺🇸
Muskegon, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸
Port Huron, Michigan, United States
Big Sky Oncology
🇺🇸
Great Falls, Montana, United States
St. Peter's Hospital
🇺🇸
Helena, Montana, United States
Kalispell Regional Medical Center
🇺🇸
Kalispell, 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
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Clifton Springs, New York, United States
Wayne Radiation Oncology
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Goldsboro, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸
Goldsboro, North Carolina, United States
Interlakes Oncology/Hematology PC
🇺🇸
Rochester, New York, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸
Middletown, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Rutherford Hospital
🇺🇸
Rutherfordton, North Carolina, United States
Wilson Medical Center
🇺🇸
Wilson, North Carolina, United States
Community Oncology Group at Cleveland Clinic Cancer Center
🇺🇸
Independence, Ohio, United States
Cleveland Clinic - Wooster
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Wooster, Ohio, United States
Medical City Dallas Hospital
🇺🇸
Dallas, Texas, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Spartanburg, South Carolina, United States
Brooke Army Medical Center
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Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
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Lackland AFB, Texas, United States
St. Joseph Cancer Center
🇺🇸
Bellingham, Washington, United States
Danville Regional Medical Center
🇺🇸
Danville, Virginia, United States
Olympic Hematology and Oncology
🇺🇸
Bremerton, Washington, United States
CCOP - Scott and White Hospital
🇺🇸
Temple, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸
Seattle, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸
Mt. Vernon, Washington, United States
Polyclinic First Hill
🇺🇸
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸
Seattle, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸
Sedro-Wooley, Washington, United States
Wenatchee Valley Medical Center
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Wenatchee, Washington, United States
Cancer Care Northwest - Spokane South
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Spokane, Washington, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States
Cancer Therapy and Research Center
🇺🇸
San Antonio, Texas, United States
University Hospital - San Antonio
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San Antonio, Texas, United States
Cancer Center of Kansas, PA - Winfield
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Winfield, Kansas, United States
Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, United States
Cancer Center of Kansas, PA - Kingman
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Kingman, Kansas, United States
Cancer Center of Kansas, PA - Newton
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Newton, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸
Pratt, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸
Salina, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸
Salina, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸
Wichita, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
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El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Chanute
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Chanute, 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 - Dodge City
🇺🇸
Dodge City, Kansas, United States
Southwest Medical Center
🇺🇸
Liberal, Kansas, United States
Stormont-Vail Cancer Center
🇺🇸
Topeka, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸
Parsons, Kansas, United States
St. Francis Comprehensive Cancer Center
🇺🇸
Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸
Wellington, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸
Sheridan, Wyoming, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
CCOP - Montana Cancer Consortium
🇺🇸
Billings, Montana, United States
St. Vincent Healthcare
🇺🇸
Billings, Montana, United States
Kalispell Medical Oncology
🇺🇸
Kalispell, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
🇺🇸
Billings, Montana, United States
Bozeman Deaconess Hospital
🇺🇸
Bozeman, Montana, United States