Imatinib Mesylate, Gemcitabine, and Capecitabine in Treating Patients With Advanced Solid Tumors

Inclusion Criteria:

* Histologically confirmed solid tumor, meeting 1 of the following criteria:

  * Failed standard therapy and subsequent line therapy
  * Disease for which no standard therapy exists
* Any number of prior therapies are allowed provided standard treatment options have either been exhausted or are unable to be administered, in the opinion of the treating physician
* Measurable or nonmeasurable disease

  * Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by CT scan or ≥ 10 mm by spiral CT scan
  * Nonmeasurable disease is defined as all other lesions, including small lesions (\< 20 mm by conventional techniques or \< 10 mm by spiral CT scan) and truly nonmeasurable lesions, including the following:

    1. Leptomeningeal disease
    2. Bone lesions
    3. Ascites
    4. Pleural or pericardial effusion
    5. Lymphangitis cutis/pulmonis
    6. Abdominal masses that are not confirmed and followed by imaging techniques
    7. Cystic lesions
* Brain metastases allowed provided both of the following are true:

  * Patient has undergone resection and/or radiotherapy and does not require steroids
  * No evidence of disease progression by CT scan or MRI at least 4 weeks after completion of steroids, surgery, and/or radiotherapy
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.5 g/dL (epoetin alfa supplementation allowed)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) (except if due to Gilbert's syndrome)
* AST and ALT ≤ 2.5 times ULN
* Creatinine \< 1.5 times ULN
* Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment
* Must be able to tolerate oral intake for the administration of imatinib mesylate and capecitabine
* Prior treatment with gemcitabine hydrochloride, capecitabine, or imatinib mesylate allowed provided all three drugs were not used in combination simultaneously
* Prior radiotherapy allowed provided the lesion treated is not used to assess response and has not demonstrated progression after treatment
* At least 2 weeks since prior radiotherapy
* More than 2 weeks since prior major surgery
* At least 4 weeks since prior systemic therapy (6 weeks for nitrosoureas) and recovered
* More than 4 weeks since prior packed red blood cell transfusions
* Concurrent bisphosphonate therapy allowed for skeletal metastases provided therapy is started before study entry

Exclusion Criteria:

* Not pregnant or nursing/negative pregnancy test
* No active serious infections
* No known allergy or hypersensitivity to study drugs or their formulation
* No comorbidity or condition which would preclude study participation
* No other primary malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or another primary malignancy that is not currently clinically significant or requires active intervention
* No prior radiotherapy to ≥ 25% of the bone marrow
* No concurrent anticoagulation therapy with warfarin

  * Therapeutic anticoagulation with low-molecular weight heparin or heparin allowed
  * Mini-dose warfarin (e.g., 1 mg/day) for prophylaxis of central venous catheter thrombosis allowed at the discretion of the treating physician
* No other concurrent anticancer agents, including chemotherapy and biologic agents
* No other concurrent investigational drugs
* No concurrent routine systemic corticosteroid therapy (corticosteroid therapy may only be administered after consultation with the principal investigator)
* No other malignant disease
* No New York Heart Association class III-IV cardiac disease
* No congestive heart failure
* No myocardial infarction within the past 6 months
* No known chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
* No known HIV infection
* No prior radiotherapy to ≥ 25% of the bone marrow
* No concurrent anticoagulation therapy with warfarin

  * Therapeutic anticoagulation with low-molecular weight heparin or heparin allowed
  * Mini-dose warfarin (e.g., 1 mg/day) for prophylaxis of central venous catheter thrombosis allowed at the discretion of the treating physician
* No other concurrent anticancer agents, including chemotherapy and biologic agents
* No other concurrent investigational drugs
* No concurrent routine systemic corticosteroid therapy (corticosteroid therapy may only be administered after consultation with the principal investigator)