Phase I of Trastuzumab and Imatinib Mesylate (Gleevec®, Formerly Known as STI-571) in Patients With Recurrent or Metastatic Her-2/Neu Expressing Cancer

Inclusion 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