Status:
COMPLETED
S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividin...
Detailed Description
OBJECTIVES: * Determine the response rate (complete and partial, confirmed and unconfirmed) in women with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine. * Determine ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IV breast cancer
- Metastatic disease (M1) OR multiple sites of new disease that is clinically obvious metastatic disease (i.e., multiple sites of new osseous disease)
- Meets 1 of the following criteria:
- Measurable disease
- Non-measurable disease
- MUC-1 antigen level \> 2 times upper limit of normal AND level has increased by 1.5 times
- Must have documented MUC-1 antigen level
- Either cancer antigen (CA) 15-3 or CA 27-29 allowed
- Must have received at least 1 prior hormonal therapy for metastatic disease (estogen receptor-positive patients only)
- No symptomatic brain or CNS metastases
- Previously treated brain or CNS metastasis allowed provided radiotherapy was completed ≥ 8 weeks before study entry
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- Zubrod 0-2
- Life expectancy
- Not specified
- Hematopoietic
- No known existing uncontrolled coagulopathy
- Hepatic
- Not specified
- Renal
- Creatinine clearance \> 40 mL/min
- Cardiovascular
- No congestive heart failure
- No symptomatic coronary artery disease
- No cardiac arrhythmia not well controlled with medication
- No myocardial infarction within the past 12 months
- No other clinically significant cardiac disease
- Gastrointestinal
- Able to take oral medication
- No uncontrolled nausea, vomiting, or diarrhea
- No lack of physical integrity of the upper gastrointestinal tract
- No malabsorption syndrome
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active infection requiring systemic therapy
- No prior severe reaction to fluoropyrimidines
- No known sensitivity to fluorouracil
- No known dihydropyrimidine dehydrogenase deficiency
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent immunotherapy or biologic therapy for breast cancer
- No concurrent gene therapy for breast cancer
- No concurrent filgrastim (G-CSF)
- Chemotherapy
- At least 14 days since prior chemotherapy and recovered
- No more than 2 prior chemotherapy regimens for metastatic disease
- No prior capecitabine for metastatic disease
- No prior oral cyclophosphamide for metastatic disease
- Prior IV cyclophosphamide allowed
- No other concurrent chemotherapy for breast cancer
- Endocrine therapy
- See Disease Characteristics
- No concurrent hormonal therapy for breast cancer
- Radiotherapy
- See Disease Characteristics
- At least 14 days since prior radiotherapy to non-CNS disease sites and recovered
- No concurrent radiotherapy for breast cancer
- Surgery
- Not specified
- Other
- Concurrent bisphosphonates allowed
- No concurrent full-dose warfarin
- Concurrent prophylactic warfarin (≤ 1 mg/day) to maintain port patency allowed
- No other concurrent antineoplastic therapy for breast cancer
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00107276
Start Date
August 1 2005
End Date
August 1 2009
Last Update
July 18 2013
Active Locations (145)
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1
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
2
Providence Cancer Center
Anchorage, Alaska, United States, 99508
3
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Eden Medical Center
Castro Valley, California, United States, 94546