Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery

NCT ID: NCT00015886

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31
• Study Completion Date: 2009-07-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.

Detailed Description

OBJECTIVES:

• Determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or third-line chemotherapy.
• Evaluate the toxic effects of this regimen in these patients.
• Determine the time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour followed by fluorouracil IV over 5 minutes on days 1-3. Treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 44 months.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

75 milligrams per meter squared intraveneously

Intervention Type: DRUG

fluorouracil

350 milligrams intraveneously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Metastatic or unresectable local disease
• Measurable or evaluable disease
• No ascites or pleural effusion as only metastatic site
• No brain or leptomeningeal metastases
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Granulocyte count greater than 1,500/mm3
• Platelet count greater than 100,000/mm3

Hepatic:

• Bilirubin normal
• SGOT/SGPT less than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase less than 2.5 times ULN

Renal:

• Creatinine no greater than 2 times ULN

Cardiovascular:

• Adequate cardiac function
• No history of significant atherosclerotic coronary disease (e.g., uncontrolled angina)
• No history of significant cardiac arrhythmia

Other:

• No serious medical or psychiatric illness that would preclude study
• No active uncontrolled bacterial, viral, or fungal infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior high-dose chemotherapy and autologous transplantation

Chemotherapy:

• At least 3 weeks since prior chemotherapy and recovered
• No more than 2 prior chemotherapy regimens for metastatic breast cancer (in addition to adjuvant therapy)
• No prior docetaxel
• No prior high-dose chemotherapy and autologous transplantation
• Prior paclitaxel allowed

Endocrine therapy:

• No concurrent hormonal therapy, except as contraception

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered
• Concurrent radiotherapy for relief of localized pain or obstruction allowed

Surgery:

• At least 2 weeks since prior major surgery and recovered

Other:

• No other concurrent cytotoxic agents

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gretchen Kimmick, MD, MS

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

East Carolina University School of Medicine

Greenville, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Palmetto Hematology/Oncology Associates

Spartanburg, South Carolina, United States

Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

CCCWFU-74896

Identifier Type: -

Identifier Source: secondary_id

NCI-3137

Identifier Type: -

Identifier Source: secondary_id

CDR0000068567

Identifier Type: -

Identifier Source: org_study_id