Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer

OBJECTIVES:

Primary

• Determine the response rate in patients with locally advanced or metastatic collecting duct renal cell cancer treated with paclitaxel and carboplatin.

Secondary

• Determine the tolerability of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 14-22 patients will be accrued for this study within 4.5 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed collecting duct renal cell carcinoma

• Advanced locally recurrent or metastatic disease
• Not amenable to resection
• Measurable disease
• No active CNS metastases

• Patients with CNS metastases previously treated with surgical resection and/or radiotherapy are eligible provided there is no evidence of disease progression by head CT scan or MRI at 3 months after the completion of definitive therapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN

Renal

• Creatinine ≤ 2 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No peripheral neuropathy greater than grade 1
• No other prior malignancy except for curatively treated cancer from which the patient has been disease-free for the length of time considered appropriate for cure of the specific cancer
• No known hypersensitivity to Cremophor EL
• No active serious infection
• No other serious underlying medical condition that would preclude study therapy
• No dementia or significantly altered mental status that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No more than 2 prior biologic response modifier (BRM) regimens

• Regimens may have included interleukin-2 and/or interferon alfa
• At least 4 weeks since prior BRM therapy

Chemotherapy

• Not specified

Endocrine therapy

• Concurrent corticosteroids allowed

Radiotherapy

• See Disease Characteristics
• Prior radiotherapy allowed provided there is measurable disease that has not been irradiated OR there is clear evidence of tumor progression in an irradiated site
• At least 4 weeks since prior radiotherapy
• No concurrent external beam radiotherapy

Surgery

• See Disease Characteristics
• No concurrent major surgery

Other

• No other concurrent anticancer drugs