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.

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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.

View Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT00077129

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 27 Locations for this study

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Baptist Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
Mercy Hospital and Medical Center
Chicago Illinois, 60616, United States
Swedish Covenant Hospital
Chicago Illinois, 60625, United States
Midwest Center for Hematology/Oncology
Joliet Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville Illinois, 60048, United States
Northwest Medical Specialist, PC
Niles Illinois, 60714, United States
Swedish-American Regional Cancer Center
Rockford Illinois, 61104, United States
Hematology Oncology Associates - Skokie
Skokie Illinois, 60076, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie Illinois, 60076, United States
Midwest Cancer Research Group, Incorporated
Skokie Illinois, 60077, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
McFarland Clinic, P. C.
Ames Iowa, 50010, United States
St. Luke's Hospital
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
MeritCare Clinic - Bemidji
Bemidji Minnesota, 56601, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Medical Group
Fargo North Dakota, 58122, United States
St. Rita's Medical Center
Lima Ohio, 45801, United States
St. Luke's Hospital Cancer Center
Bethlehem Pennsylvania, 18015, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT00077129

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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