Status:
COMPLETED
Trastuzumab and Irinotecan in Treating Patients With HER2/Neu Positive Metastatic Breast Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
Up to 120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: Primary * Determine the overall objective response-rate (partial and complete) and stable disease rate in patients with HER2/neu positive metastatic breast cancer treated with the combin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic breast carcinoma
- Received 1-3 prior chemotherapy regimens for metastatic disease
- Documented progressive disease
- Repeated courses of the same chemotherapy agent alone or in combination are considered a single regimen
- Prior trastuzumab (Herceptin®) alone or with chemotherapy allowed
- Other biologic agents are not considered a chemotherapy regimen
- Measurable disease
- Patients with bone-only disease who are evaluable by tumor markers (e.g., CA15-3, CEA, or CA27.29) are eligible
- Patients must have prior evidence of correlation of disease activity with changes in tumor marker level
- Confirmation of HER2/neu status by a positive test for gene amplification by fluorescence in situ hybridization or 3+ by immunohistochemistry
- Brain metastases allowed if the following criteria are met:
- Brain metastases were previously treated and are currently stable as documented by head CT scan with contrast or MRI within 4 weeks of study entry
- Patients with existing brain metastases should have stability documented by prior imaging ≥ 8 weeks before the baseline scan
- Hormone-receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status ≤ 2
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Life expectancy ≥ 12 weeks
- No history of congestive heart failure
- Documented ejection fraction ≥ 45% by MUGA scan or echocardiogram within 1 month of study entry
- Total bilirubin \< 3 times upper limit of normal (ULN)
- AST \< 3 times ULN (5 times ULN if due to liver involvement)
- Creatinine \< 1.5 times ULN
- No history of serious adverse events related to trastuzumab
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No severe, concurrent illness that would prevent compliance with study protocol
- No chronic severe diarrheal illness
- No history of Gilbert's disease or known deficiency in glucuronidation
- No recent or current history of alcoholism or acute viral hepatitis
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No chemotherapy or hormonal therapy within the past 2 weeks
- Prior or concurrent bisphosphonates allowed
- No prior irinotecan (other camptothecins allowed)
- No concurrent radiotherapy
- No ongoing treatment with any other investigational agent
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00303992
Start Date
May 1 2004
End Date
January 1 2013
Last Update
January 17 2018
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115-1710