phase i study of osi-930 and erlotinib in cancer tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase i, dose escalation, safety study of osi-930 and erlotinib in cancer tumors.

multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of osi-930 and erlotinib. patients may continue to receive osi-930 and erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Eligibility criteria:
inclusion criteria: * histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists * age greater than or equal to 18 years * ecog ps 0-2 * anc greater than or equal to 1.5 x 10\^9/l * bilirubin less than or equal to 1.5 x upper limit of normal (uln), ast and alt less than or equal to 2.5 x uln * creatinine less than or equal to 1.5 uln * predicted life expectancy greater than or equal to 12 weeks * prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed * prior tyrosine kinase inhibitor therapy is permitted * patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration * prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months) * prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects (a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive) * prior surgery is permitted, provided that wound healing has occurred prior to registration * patients must use proactive effective contraceptive measures throughout the study * provide written informed consent * accessible for repeat dosing and follow-up * adequate hematopoietic, hepatic, and renal function exclusion criteria: * significant cardiac disease unless well controlled * current or former smokers, unless patients stopped smoking greater than 3 months prior to registration * active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation * history of unacceptable toxicity with previous egfr inhibitor therapy * history of any psychiatric condition that might impair the patient's ability to provide informed consent or participate * use of cyp3a4 inducers/inhibitors during the 14 days prior to first dose * pregnant or breast-feeding females * symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days * history of allergic reaction attributed to a similar compound as study drug * gi abnormalities including inability to take oral medications, required for iv alimentation * clinically significant ophthalmologic abnormalities

Keywords: gist ovarian cancer mesothelioma renal colorectal cancer sarcoma nsclc cancer