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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
paclitaxel
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Cancer Institute - Jacksonville
  • Rush-Copley Cancer Care Center
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Hematology and Oncology Associates
  • Veterans Affairs Medical Center - Lakeside Chicago
  • Mercy Hospital and Medical Center
  • Swedish Covenant Hospital
  • Midwest Center for Hematology/Oncology
  • Joliet Oncology-Hematology Associates, Limited - West
  • North Shore Oncology and Hematology Associates, Limited - Libertyville
  • Northwest Medical Specialist, PC
  • Swedish-American Regional Cancer Center
  • Hematology Oncology Associates - Skokie
  • Hematology/Oncology of the North Shore at Gross Point Medical Center
  • Midwest Cancer Research Group, Incorporated
  • Carle Cancer Center at Carle Foundation Hospital
  • CCOP - Carle Cancer Center
  • Saint Anthony Memorial Health Centers
  • McFarland Clinic, P. C.
  • St. Luke's Hospital
  • Cedar Rapids Oncology Associates
  • Mercy Regional Cancer Center at Mercy Medical Center
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • MeritCare Clinic - Bemidji
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • CCOP - MeritCare Hospital
  • MeritCare Medical Group
  • St. Rita's Medical Center
  • St. Luke's Hospital Cancer Center
  • Avera Cancer Institute
  • Medical X-Ray Center, PC
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

Outcomes

Primary Outcome Measures

Proportion of patients with clinical response

Secondary Outcome Measures

Toxicity

Full Information

First Posted
February 10, 2004
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077129
Brief Title
Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
Official Title
Phase II Trial Of Paclitaxel Plus Carboplatin In Patients With Metastatic Or Locally Advanced Collecting Duct Renal Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2006 (Actual)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Proportion of patients with clinical response
Secondary Outcome Measure Information:
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F. McDermott, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael B. Atkins, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Baptist Cancer Institute - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Rush-Copley Cancer Care Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60507
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Hematology and Oncology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
Midwest Center for Hematology/Oncology
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Limited - West
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
North Shore Oncology and Hematology Associates, Limited - Libertyville
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Northwest Medical Specialist, PC
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Swedish-American Regional Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104-2315
Country
United States
Facility Name
Hematology Oncology Associates - Skokie
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Hematology/Oncology of the North Shore at Gross Point Medical Center
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Midwest Cancer Research Group, Incorporated
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Carle Cancer Center at Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Saint Anthony Memorial Health Centers
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
McFarland Clinic, P. C.
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
St. Luke's Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Cedar Rapids Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
MeritCare Clinic - Bemidji
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
MeritCare Medical Group
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
St. Rita's Medical Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
St. Luke's Hospital Cancer Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center, PC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sioux Valley Hospital and University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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