Status:
COMPLETED
Trastuzumab and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic HER2/Neu-Expressing Cancer
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Imatinib mesylate may stop th...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of imatinib mesylate when administered with trastuzumab (Herceptin®) in patients with recurrent or metastatic HER2/neu-overexpressing cance...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed cancer that overexpresses HER2/neu, measured 3+ by immunohistochemistry or positive by fluorescence in situ hybridization
- Recurrent or metastatic disease
- Meets 1 of the following criteria for measurable or evaluable disease:
- Unidimensionally measurable disease at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Evaluable disease, defined as a lesion on physical examination or imaging study that can be assessed as to changes in size but cannot be clearly measured in 1 dimension (e.g., pleural effusions, ascites, or bone disease)
- No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease
- Prior controlled brain parenchymal disease allowed provided at least 8 weeks since prior therapy AND no symptomatic progression off corticosteroids
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- ALT and AST ≤ 2.0 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.0 times ULN
- Bilirubin ≤ 1.3 mg/dL
- No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
- Renal
- Creatinine ≤ 2.0 mg/dL
- Cardiovascular
- Ejection fraction ≥ lower limit of normal by MUGA
- No uncontrolled or significant cardiovascular disease
- No myocardial infarction within the past 6 months
- No ischemic heart disease requiring medication
- No congestive heart failure
- Pulmonary
- No uncontrolled or significant pulmonary disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- No active unresolved infection
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior trastuzumab (Herceptin®) allowed
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) to support blood counts
- No other concurrent anticancer biologic agents
- Chemotherapy
- Prior chemotherapy for metastatic disease allowed
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent anticancer chemotherapy
- Endocrine therapy
- See Disease Characteristics
- Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- Surgery
- More than 2 weeks since prior major surgery
- Other
- At least 7 days since prior antibiotics
- No concurrent parenteral antibiotics
- No other concurrent anticancer agents
- No other concurrent investigational drugs
- No concurrent therapeutic anticoagulation with warfarin
- Concurrent mini-dose warfarin (1 mg/day) for prophylaxis of central venous catheter thrombosis allowed
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00084513
Start Date
August 1 2004
End Date
March 1 2007
Last Update
February 12 2010
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497