Status:
TERMINATED
Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of the combination of metronomic dose cyclophosphamide and methotrexate with continuous dosing sunitinib malate. (Phase I) * To determin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed diagnosis of breast cancer with documented progressive disease
- Metastatic disease
- Measurable disease as defined by RECIST criteria or evaluable disease
- Must have received at least one prior chemotherapy regimen for metastatic breast cancer
- Patients refusing all other chemotherapy for breast cancer may enroll without prior treatment
- Patients with HER2-overexpression disease must have been previously treated with trastuzumab (Herceptin®)
- Patients with stable brain metastases are eligible
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 12 weeks
- Absolute Neutrophil Count (ANC) ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
- Total bilirubin ≤ 1.5 times ULN
- Able to take oral medications and maintain hydration
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after treatment
- No severe concurrent illness including, but not limited to, any of the following:
- Congestive heart failure
- Significant cardiac disease
- Uncontrolled hypertension
- Must be able to read and speak English
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 weeks since prior treatment, including chemotherapy, hormonal therapy, trastuzumab (Herceptin®), or other targeted therapies
- Prior bevacizumab allowed if discontinued for any reason other than toxicity
- No potent inducers or inhibitors of CYP3A4 enzymes that effect the metabolism of sunitinib malate
- No prior sunitinib malate
- No other concurrent investigational therapy
- No concurrent radiotherapy
- Concurrent bisphosphonates allowed
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00616122
Start Date
March 1 2006
End Date
December 1 2012
Last Update
January 13 2020
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94115