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

Phase 2

Completed

• Conditions: Lung Cancer; Adenocarcinoma

• Registration Number: NCT00430261
• Lead Sponsor: Swedish Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-05
• Last Update Posted: 2010-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	January 2009

Trial Locations

Locations (1)

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States