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

SWOG Cancer Research Network

Status and phase

Terminated

Phase 2

Conditions

Transitional Cell Cancer of the Renal Pelvis and Ureter

Bladder Cancer

Urethral Cancer

Treatments

Drug: gemcitabine hydrochloride

Drug: paclitaxel

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00022633

S0028 (Other Identifier)

CDR0000068837

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

Under 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)
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: