Lung Cancer

Pfizer A6181087

A study treating patients with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) with both Erlotinib and Sunitinib.

Principal Investigator:
Haskell Kirkpatrick, M.D.

Co-Investigators:
Minal A. Barve, M.D.
James F. Strauss, M.D.
Chiyu Wang, M.D.
Lalan S. Wilfong, M.D.
Jaya V. Juturi, M.D.
Kiran R. Kancharla, M.D.
Gabriel A. Shapiro, M.D.
Jivesh J. Sharma, M.D.

Purpose:
Lung cancer is the leading cause of cancer death in the US and Europe. This clinical trial studies the effectiveness of adding Sunitinib to Erlotinib in treating patients with advanced/metastatic non-small cell lung cancer (NSCLC). Erlotinib has been FDA-approved for the treatment of NSCLC but Sunitinib is investigational.

Patients who enroll in this study will receive oral Sunitinib or a Sunitinib placebo for as long as they continue to benefit from the medication. All subjects will have their medical condition followed for life.

Eligibility (this is not a comprehensive list)

• Must be at least 18 years of age.
• Have a diagnosis of NSCLC with evidence of disease that is recurrent (after treatment for Stage IIIB with malignant effusion or Stage IV NSCLC).
• Have been unresponsive to prior treatment with 1 or 2 chemotherapy regimens (including a platinum-based regimen) for advanced disease.
• No second malignancy within the last 3 years except for adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix uteri.
• No major surgery or anti-cancer therapy for 4 weeks.
• No prior treatment with any receptor tyrosine kinase inhibitors (including sunitinib, erlotinib and geftinib), VEGF inhibitors (except bevacizumab), or other angiogenesis inhibitors (including thalidomide), platinum-based regimen, high-dose chemotherapy requiring hematopoietic stem cell rescue, radiation to >25% of the bone marrow.
• No current or history of brain metastases, spinal cord compression, carcinomatous meningitis or leptomeningeal disease or second malignancy within the last 3 years.
• No ongoing grade ≥ 2 cardiac dysrhythmias, atrial fibrillation, or > 450msec QTc interval, uncontrolled hypertension, HIV, severe dry eye syndrome, Sjogren's syndrome, keratopathy, aniridia, severe chemical burns, neutrophilic keratitis, clinically significant gastrointestinal abnormalities, other severe acute or chronic medical or psychiatric condition.