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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with clinical response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer