Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Ca… (NCT00077129) | Clinical Trial Compass
CompletedPhase 2
Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
United States22 participantsStarted 2006-06-01
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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 respons…