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

Tracking Information

First Received Date ^ICMJE

August 10, 2001

Last Updated Date

July 23, 2008

Start Date ^ICMJE

July 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Study treatment feasibility [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Study treatment feasibility

Change History

Complete list of historical versions of study NCT00022633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Objective response rate (confirmed and unconfirmed complete and partial response)
Survival at 2 years
Toxicity and tolerability
Feasibility of standardized self-report measures of comorbidity, depression, and functional status
Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: gemcitabine hydrochloride
Drug: paclitaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00022633

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068837, SWOG-S0028

Study Sponsor ^ICMJE

Southwest Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP