Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	70 and over OR under 60	NCI	SWOG-S0028 S0028, NCT00022633

Objectives

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

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Study treatment feasibility

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

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Derek Raghavan, MD, PhD, FRACP, FACP, Protocol chair		Ph: 216-445-6888; 800-862-7798
Maha Hadi Hussain, MD, Protocol co-chair		Ph: 734-936-8906; 800-865-1125

Registry Information
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)
Trial Start Date		2001-07-01
Registered in ClinicalTrials.gov		NCT00022633
Date Submitted to PDQ		2001-06-25
Information Last Verified		2006-12-15
NCI Grant/Contract Number		CA32102

Back to Top