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

Sponsor

Swedish Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00430261

Collaborator

Pfizer (Industry)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Adenocarcinoma	Drug: sunitinib	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Outcome Measures

Primary Outcome Measures

Progression-Free Survival [January 2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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