Status:
COMPLETED
Chemotherapeutic Agents in Brain/Breast
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
United States Department of Defense
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor ce...
Detailed Description
OBJECTIVES: * To determine the concentration of capecitabine, cyclophosphamide, doxorubicin hydrochloride, gemcitabine hydrochloride, lapatinib ditosylate, paclitaxel, trastuzumab (Herceptin®), or vi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed breast carcinoma with ≥ 1 suspected or known parenchymal brain metastases for which surgical resection or biopsy is clinically indicated
- Treating oncologist must agree that the patient would derive clinical benefit from receiving ≥ 1 of the following study agents:
- Capecitabine, cyclophosphamide, doxorubicin hydrochloride, gemcitabine hydrochloride, lapatinib ditosylate, paclitaxel, trastuzumab (Herceptin®), or vinorelbine ditartrate
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Karnofsky performance status 50-100%
- Life expectancy ≥ 3 months
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin (total) ≤ 1.5 times ULN
- AST ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for three months after completion of study treatment
- No severe NYHA class III-IV cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary artery disease
- No history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
- PRIOR CONCURRENT THERAPY:
- No toxicity \> grade 2 from prior chemotherapy or radiotherapy remains at the time of study entry
- At least 60 days since prior bevacizumab
- At least 4 weeks since prior cranial radiotherapy
- At least 3 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- At least 2 weeks since prior non-cytotoxic drugs (e.g., small molecule-targeted drugs)
- No concurrent experimental therapies
- Concurrent hormone therapy and/or trastuzumab (Herceptin®) allowed
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00795678
Start Date
September 1 2008
End Date
April 1 2013
Last Update
August 2 2013
Active Locations (2)
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1
Memorial Sloan Kettering
New York, New York, United States, 10065
2
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195