Kidney Cancer Clinical Trial
Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
Summary
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.
Eligibility 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
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There are 27 Locations for this study
Jacksonville Florida, 32207, United States
Aurora Illinois, 60507, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60616, United States
Chicago Illinois, 60625, United States
Joliet Illinois, 60432, United States
Joliet Illinois, 60435, United States
Libertyville Illinois, 60048, United States
Niles Illinois, 60714, United States
Rockford Illinois, 61104, United States
Skokie Illinois, 60076, United States
Skokie Illinois, 60076, United States
Skokie Illinois, 60077, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Michigan City Indiana, 46360, United States
Ames Iowa, 50010, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Bemidji Minnesota, 56601, United States
Bronx New York, 10466, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Lima Ohio, 45801, United States
Bethlehem Pennsylvania, 18015, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
La Crosse Wisconsin, 54601, United States
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