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