Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma

Brief Summary

Official Title: “Phase II Trial of Sunitinib in Bronchoalveolar Carcinoma or Never-Smokers With Any Lung Adenocarcinoma”

This is an open-label study of a new oral drug for advanced stage (IIIB or IV) lung cancer. The cancer must be EITHER bronchoalveolar carcinoma (BAC) type, or if the patient is a never-smoker (less than 100 cigarettes lifetime) the cancer can be any type of adenocarcinoma.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: October 2010

Detailed Clinical Trial Description

To participate in this study, patients must have disease that can be measured on a CT scan. Brain metastases are OK if stable. Pregnant and/or nursing women may not participate. This drug has been approved by the FDA for the treatment of advanced renal cell cancer and a certain type of stomach/intestinal cancer. Its efficacy in lung cancer in currently unknown. Common side effects include fatigue, nausea, diarrhea, skin reaction, and decreased blood counts.

Interventions Used in this Clinical Trial

  • Drug: sunitinib
    • 50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.

Outcome Measures for this Clinical Trial

Primary Measures

  • Progression-Free Survival
    • Time Frame: January 2009
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Bronchoalveolar carcinoma with disease measurable on CAT scan
  • Any lung adenocarcinoma in a never-smoker (less than 100 cigarettes lifetime) with disease measurable on CAT scan
  • Stage IIIB or IV

Exclusion Criteria

  • Uncontrolled hypertension
  • Unstable brain metastases
  • Pregnant/nursing women
  • Uncontrolled thyroid disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Swedish Medical Center
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Howard jack West, M.D., Swedish Medical Center, Swedish Cancer Institute
  • Overall Official(s)
    • Howard West, M.D., Principal Investigator, Swedish Cancer Institute


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