Dasatinib and Lapatinib Ditolsylate in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery

Inclusion Criteria:

• Histologic proof of cancer that is now unresectable and refractory to or refused all standard treatment for the disease
• Please contact study investigator and/or consult protocol document for specific details on laboratory criteria
• Ability to provide informed consent
• Willingness to return to Mayo Clinic for follow up
• Life expectancy >= 12 weeks
• Negative serum pregnancy test done =< 7 days prior to registration for women of childbearing potential only
• Echocardiogram with ejection fraction > 50%
• ECOG performance status (PS) 0-2
• Able to swallow pills whole (patients with feeding tubes may be eligible if whole pills can be taken and tolerated through the feeding tube)
• Willingness to provide the biologic specimens as required by the protocol for Cohort II, (MTD) patients only

Exclusion Criteria:

• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• Pregnant women
• Any of the following prior therapies: chemotherapy =< 4 weeks prior to registration; mitomycin C/nitrosoureas =< 6 weeks prior to registration; immunotherapy =< 4 weeks prior to registration; biologic therapy =< 4 weeks prior to registration
• Patients who have been treated with Avastin, Herceptin, or Erbitux are eligible if last treatment is >= 4 weeks; molecularly targeted agents (erlotinib, sunitinib, sorafenib, gefitinib, imatinib) =< 4 weeks prior to registration; radiation therapy =< 4 weeks prior to registration; radiation to > 25% of bone marrow
• CNS metastases that are not stable for at least 4 weeks prior to registration based on imaging, clinical assessment, and use of steroids
• Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and until 4 weeks following study
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
• Current therapy with a CYP3A4 inhibitor or inducer
• Known standard therapy for the patient's disease that is not refractory to treatment that is potentially curative or definitely capable of extending life expectancy
• Uncontrolled pleural or pericardial effusion of any grade
• Uncontrolled angina, congestive heart failure or MI within 6 months prior to registration
• Diagnosed congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
• Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
• Subjects with potassium or magnesium that are not within normal limits and cannot be corrected prior to registration
• New York Heart Association classification III or IV
• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
• Ongoing or recent (=< 3 months prior to registration) significant gastrointestinal bleeding
• Prophylactic use of colony-stimulating factors during the study is not allowed
• Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
• G.I conditions that may interfere with drug absorption such as Ulcerative Colitis, Crohn's Disease, and Short Bowel Syndrome
• Active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator's assessment)
• Nursing women
• Uncontrolled infection
• Seizure disorder