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Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
carboplatin
paclitaxel
Sponsored by
Theradex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Must have clinical evidence of stage IV (M1) disease HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown At least 1 measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Patients with bone-only disease are not eligible Ineligible if currently experiencing a complete or partial response to prior hormonal therapy Patients with disease progression after prior response to hormonal therapy are eligible Disease progression without prior hormonal therapy is allowed Stable or asymptomatic brain metastasis allowed if: Other measurable disease exists Cranial irradiation completed and brain metastasis stable for at least 4 weeks before study Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Pre- or post-menopausal Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Corrected calcium less than 12 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No documented myocardial infarction within the past 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Other: No active serious infection No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K No clinically significant (greater than grade 1) peripheral neuropathy No other serious underlying medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell transplantation More than 6 months since prior adjuvant monoclonal antibody therapy More than 6 months since prior adjuvant vaccine therapy No prior trastuzumab (Herceptin) No concurrent anticancer immunotherapy Chemotherapy: No prior chemotherapy for metastatic breast cancer More than 6 months since prior adjuvant high-dose chemotherapy More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy Prior adjuvant taxanes allowed only if administered every 3 weeks Endocrine therapy: See Disease Characteristics Any number of prior hormonal therapies for metastatic breast cancer allowed Patients with definite signs of progression may begin study therapy immediately after stopping hormonal therapy No concurrent anticancer hormonal agents (including megestrol) Radiotherapy: At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation) No prior radiotherapy to 30% or more of bone marrow No concurrent radiotherapy except for palliation of painful bone metastasis or pathologic fractures to the area of known lytic disease Surgery: At least 3 weeks since prior major surgery Other: More than 6 months since prior neoadjuvant therapy No other concurrent anticancer drugs

Sites / Locations

  • Highlands Oncology Group
  • Monterey Bay Oncology
  • Wilshire Oncology Medical Group, Inc.
  • University of California Davis Cancer Center
  • New Britain General Hospital
  • Center for Hematology and Oncology
  • Cancer Research Network, Inc.
  • Mayo Clinic
  • MacNeal Cancer Center
  • Oncology Specialists, SC
  • Maine Center for Cancer Medicine and Blood Disorders
  • Maryland Hematology/Oncology Associates
  • St. John's Mercy Medical Center
  • St. Barnabas Medical Center
  • Finger Lakes Community Cancer Center
  • Clinical Hematology & Oncology Service, Inc.
  • Scranton Hematology-Oncology
  • East Tennessee Oncology/Hematology, P.C.
  • West Clinic
  • Texas Cancer Care
  • Oncology Consultants
  • Scott and White Clinic
  • Northern Virginia Oncology Group, P.C.
  • Seattle Cancer Care Alliance
  • Dean Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
Last Updated
July 23, 2008
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00025688
Brief Title
Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
Official Title
A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if paclitaxel is more effective with or without carboplatin in treating stage IV breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.
Detailed Description
OBJECTIVES: Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer. Compare the overall survival, time to disease progression, and duration of response in these patients treated with these regimens. Compare the safety of these regimens in this patient population. Compare the quality of life of these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks. Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 3 weeks. Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each course during study, and then after completion of study. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Must have clinical evidence of stage IV (M1) disease HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown At least 1 measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Patients with bone-only disease are not eligible Ineligible if currently experiencing a complete or partial response to prior hormonal therapy Patients with disease progression after prior response to hormonal therapy are eligible Disease progression without prior hormonal therapy is allowed Stable or asymptomatic brain metastasis allowed if: Other measurable disease exists Cranial irradiation completed and brain metastasis stable for at least 4 weeks before study Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Pre- or post-menopausal Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Corrected calcium less than 12 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No documented myocardial infarction within the past 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Other: No active serious infection No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K No clinically significant (greater than grade 1) peripheral neuropathy No other serious underlying medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell transplantation More than 6 months since prior adjuvant monoclonal antibody therapy More than 6 months since prior adjuvant vaccine therapy No prior trastuzumab (Herceptin) No concurrent anticancer immunotherapy Chemotherapy: No prior chemotherapy for metastatic breast cancer More than 6 months since prior adjuvant high-dose chemotherapy More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy Prior adjuvant taxanes allowed only if administered every 3 weeks Endocrine therapy: See Disease Characteristics Any number of prior hormonal therapies for metastatic breast cancer allowed Patients with definite signs of progression may begin study therapy immediately after stopping hormonal therapy No concurrent anticancer hormonal agents (including megestrol) Radiotherapy: At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation) No prior radiotherapy to 30% or more of bone marrow No concurrent radiotherapy except for palliation of painful bone metastasis or pathologic fractures to the area of known lytic disease Surgery: At least 3 weeks since prior major surgery Other: More than 6 months since prior neoadjuvant therapy No other concurrent anticancer drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edith A. Perez, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Monterey Bay Oncology
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc.
City
Pomona
State/Province
California
ZIP/Postal Code
91767-3021
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
New Britain General Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Center for Hematology and Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Cancer Research Network, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
MacNeal Cancer Center
City
Berwyn
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Facility Name
Oncology Specialists, SC
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Maryland Hematology/Oncology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Finger Lakes Community Cancer Center
City
Clifton Springs
State/Province
New York
ZIP/Postal Code
14432
Country
United States
Facility Name
Clinical Hematology & Oncology Service, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Scranton Hematology-Oncology
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
East Tennessee Oncology/Hematology, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Cancer Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Scott and White Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Northern Virginia Oncology Group, P.C.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Dean Medical Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

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Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer

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