Phase I of Trastuzumab and Imatinib Mesylate (Gleevec®, Formerly Known as STI-571) in Patients With Recurrent or Metastatic Her-2/Neu Expressing Cancer
Data Collection
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the maximum tolerated dose of imatinib mesylate when administered with trastuzumab (Herceptin®) in patients with recurrent or metastatic HER2/neu-overexpressing cancer. * Determine response in patients treated with this regimen. Secondary * Correlate the number of circulating tumor cells with radiographic imaging in patients treated with this regimen. OUTLINE: This is a dose-escalation study of imatinib mesylate. Patients receive trastuzumab (Herceptin®) IV over 90 minutes on day 1 and oral imatinib mesylate once or twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 9-18 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location