Clinical trial NCT00015886: Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
Official title: Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-10-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
timeFrame: 28 weeks
Secondary outcomes:
measure: To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University School of Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Spartanburg
country: United States
facility: Palmetto Hematology/Oncology Associates
state: South Carolina
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gretchen Kimmick, MD, MS
role: STUDY_CHAIR
References: