Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00015886

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There are 6 Locations for this study

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Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
East Carolina University School of Medicine
Greenville North Carolina, 27858, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Cancer Centers of the Carolinas
Greenville South Carolina, 29605, United States
Palmetto Hematology/Oncology Associates
Spartanburg South Carolina, 29303, United States
Massey Cancer Center
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00015886

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

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