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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00015886
• Other study ID #: CDR0000068567
• Secondary ID: CCCWFU-74896NCI-
• Status: Completed
• Phase: Phase 2
• Start date: January 1997
• Est. completion date: July 2009

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2009
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel
75 milligrams per meter squared intraveneously
• fluorouracil
350 milligrams intraveneously

Locations

Country	Name	City	State
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	East Carolina University School of Medicine	Greenville	North Carolina
United States	Massey Cancer Center	Richmond	Virginia
United States	Palmetto Hematology/Oncology Associates	Spartanburg	South Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil		28 weeks
Secondary	To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil		28 weeks