MedPath

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

Phase 2
Completed
Conditions
Kidney Cancer
Registration Number
NCT00077129
Lead Sponsor
Eastern Cooperative Oncology Group
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of patients with clinical response
Secondary Outcome Measures
NameTimeMethod
Toxicity

Trial Locations

Locations (35)

Baptist Cancer Institute - Jacksonville

🇺🇸

Jacksonville, Florida, United States

Saint Anthony Memorial Health Centers

🇺🇸

Michigan City, Indiana, United States

Midwest Cancer Research Group, Incorporated

🇺🇸

Skokie, Illinois, United States

McFarland Clinic, P. C.

🇺🇸

Ames, Iowa, United States

St. Luke's Hospital

🇺🇸

Cedar Rapids, Iowa, United States

Carle Cancer Center at Carle Foundation Hospital

🇺🇸

Urbana, Illinois, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

Cedar Rapids Oncology Associates

🇺🇸

Cedar Rapids, Iowa, United States

Mercy Regional Cancer Center at Mercy Medical Center

🇺🇸

Cedar Rapids, Iowa, United States

Medical X-Ray Center, PC

🇺🇸

Sioux Falls, South Dakota, United States

Borgess Medical Center

🇺🇸

Kalamazoo, Michigan, United States

West Michigan Cancer Center

🇺🇸

Kalamazoo, Michigan, United States

St. Luke's Hospital Cancer Center

🇺🇸

Bethlehem, Pennsylvania, United States

MeritCare Clinic - Bemidji

🇺🇸

Bemidji, Minnesota, United States

St. Rita's Medical Center

🇺🇸

Lima, Ohio, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

🇺🇸

La Crosse, Wisconsin, United States

Hematology and Oncology Associates

🇺🇸

Chicago, Illinois, United States

MeritCare Medical Group

🇺🇸

Fargo, North Dakota, United States

CCOP - MeritCare Hospital

🇺🇸

Fargo, North Dakota, United States

Bronson Methodist Hospital

🇺🇸

Kalamazoo, Michigan, United States

Sioux Valley Hospital and University of South Dakota Medical Center

🇺🇸

Sioux Falls, South Dakota, United States

Rush-Copley Cancer Care Center

🇺🇸

Aurora, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

🇺🇸

Chicago, Illinois, United States

Mercy Hospital and Medical Center

🇺🇸

Chicago, Illinois, United States

North Shore Oncology and Hematology Associates, Limited - Libertyville

🇺🇸

Libertyville, Illinois, United States

Hematology/Oncology of the North Shore at Gross Point Medical Center

🇺🇸

Skokie, Illinois, United States

Midwest Center for Hematology/Oncology

🇺🇸

Joliet, Illinois, United States

Swedish-American Regional Cancer Center

🇺🇸

Rockford, Illinois, United States

Swedish Covenant Hospital

🇺🇸

Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago

🇺🇸

Chicago, Illinois, United States

Hematology Oncology Associates - Skokie

🇺🇸

Skokie, Illinois, United States

Northwest Medical Specialist, PC

🇺🇸

Niles, Illinois, United States

Joliet Oncology-Hematology Associates, Limited - West

🇺🇸

Joliet, Illinois, United States

Our Lady of Mercy Medical Center Comprehensive Cancer Center

🇺🇸

Bronx, New York, United States

Avera Cancer Institute

🇺🇸

Sioux Falls, South Dakota, United States

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