Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002662
• Other study ID #: AVENTIS-56976-TAX-311
• Secondary ID: CDR0000064232RP-
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: August 1, 2013
• Start date: August 1994
• Est. completion date: June 2004

Study information

• Verified date: April 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 whether paclitaxel is more effective than docetaxel for breast cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.

Description:

OBJECTIVES:

• Compare the response rate in women with metastatic or locally advanced, inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel.

• Compare the toxicity of these regimens in these patients.

• Compare the time to disease progression, duration of response, quality of life, and survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after courses 4 and 6.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast

• Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or CT or abdominal CT do not require histologic confirmation)

• Hot spots on bone scan not shown to be malignant on plain x-rays are not adequate evidence of malignant disease in the absence of other lesions

• Must meet 1 of the following conditions:

• Disease progression after 1 prior chemotherapy regimen for locally advanced or metastatic disease (which may or may not have followed a separate adjuvant regimen using chemotherapy or hormonal therapy)

• Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant chemotherapy regimen

• One of the above chemotherapy regimens must have contained an anthracycline (e.g., doxorubicin, but not mitoxantrone)

• Single drug substitution (e.g., methotrexate for doxorubicin) during prior combination chemotherapy allowed

• Bidimensionally measurable

• No clinical or radiographic evidence of brain or leptomeningeal disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 60-100% OR

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin normal

• SGOT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL

• No uncontrolled hypercalcemia

Cardiovascular:

• No myocardial infarction within the past 6 months

• No history of arrhythmia requiring treatment

• No heart block

• No clinical evidence of congestive heart failure

• No unstable angina (e.g., new onset, crescendo, or rest angina)

• Stable exertional angina allowed

Other:

• No current symptomatic grade 2 or greater peripheral neuropathy

• No history of hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide)

• No serious infection

• No significant psychiatric disease that would preclude study

• No other malignancy within the past 5 years except nonmelanomatous skin cancer or completely excised carcinoma in situ of the cervix

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior bone marrow or stem cell transplantation

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6 weeks for nitrosoureas or mitomycin)

• No prior high-dose chemotherapy given with ablative intent

• No prior taxoids

• No other concurrent antineoplastic therapy

Endocrine therapy:

• See Disease Characteristics

• Prior hormonal therapy as adjuvant therapy or for metastatic disease allowed

• At least 1 week since prior hormonal therapy

• No concurrent corticosteroids except:

• Prophylaxis or treatment for acute hypersensitivity reactions

• Chronic therapy (more than 6 months) at low doses (20 mg/day or less of methylprednisolone or equivalent)

Radiotherapy:

• At least 4 weeks since prior radiotherapy to major bone marrow areas

• No prior high-dose radiotherapy given with ablative intent

• No concurrent radiotherapy except limited palliative radiotherapy (e.g., for a solitary rib fracture) during objective response

Surgery:

• See Disease Characteristics

• More than 2 weeks since prior surgery except simple biopsy or placement of venous access device

Other:

• At least 4 weeks since prior investigational drugs

• Concurrent medications known to alter cardiac conduction (e.g., digoxin, beta blockers, or calcium channel blockers) allowed

• No concurrent ketoconazole

• No concurrent bisphosphonates unless initiated more than 3 months before randomization

• No concurrent experimental drug or therapy

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel

• paclitaxel

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Montclair Regional Cancer Center	Birmingham	Alabama
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Carolinas Hematology-Oncology Associates	Charlotte	North Carolina
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Hematology Oncology Consultants Inc	Columbus	Ohio
United States	Charles A. Sammons Cancer Center	Dallas	Texas
United States	Georgia Cancer Specialists - DeKalb	Decatur	Georgia
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado
United States	Highlands Oncology Group, P.A. - Fayetteville	Fayetteville	Arkansas
United States	California Cancer Care, Inc.	Greenbrae	California
United States	Greenville Hospital System	Greenville	South Carolina
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Baptist Regional Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Northeast Arkansas Clinic	Jonesboro	Arkansas
United States	Baptist Regional Cancer Center - Knoxville	Knoxville	Tennessee
United States	Green Cancer Center at Scripps Clinic	La Jolla	California
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Norwich Cancer Center	Norwich	Connecticut
United States	Oncology-Hematology Associates	Philadelphia	Pennsylvania
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	Mercy Arch Hematology Oncology, P.C.	Saint Louis	Missouri
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Sidney Kimmel Cancer Center	San Diego	California
United States	Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Scarborough	Maine
United States	Southfield Oncology Institute, Inc.	Southfield	Michigan
United States	George Washington University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Aventis Pharmaceuticals

Country where clinical trial is conducted

United States,