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Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil

Outcome Time Frame:

28 weeks

Safety Issue:

No

Principal Investigator

Gretchen Kimmick, MD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000068567

NCT ID:

NCT00015886

Start Date:

January 1997

Completion Date:

July 2009

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Massey Cancer CenterRichmond, Virginia  23298-0037
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Palmetto Hematology/Oncology AssociatesSpartanburg, South Carolina  29303
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534