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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: paclitaxel; Drug: carboplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00077129

E2803

CDR0000349502

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with locally advanced or metastatic collecting duct renal cell cancer that cannot be removed by surgery.

Full description

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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