Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Phase I Study of OSI-930 and Erlotinib in Cancer Tumors

Summary: This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

Detailed description: 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: 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

Relevance to patient case: not relevant