Back to resultsPhase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma
Primary Purpose
Lung Cancer, Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring bronchoalveolar carcinoma, BAC, adenocarcinoma, lung cancer, oral, Stage IIIB and IV lung cancer, Any bronchoalveolar carcinoma (BAC), Any adenocarcinoma in a never-smoker
Eligibility Criteria
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
Sites / Locations
- Swedish Cancer Institute
Outcomes
Primary Outcome Measures
Progression-Free Survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00430261
First Posted
January 30, 2007
Last Updated
October 5, 2010
Sponsor
Swedish Medical Center
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00430261
Brief Title
Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma
Official Title
Phase II Trial of Sunitinib in Bronchoalveolar Carcinoma or Never-Smokers With Any Lung Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Swedish Medical Center
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Adenocarcinoma
Keywords
bronchoalveolar carcinoma, BAC, adenocarcinoma, lung cancer, oral, Stage IIIB and IV lung cancer, Any bronchoalveolar carcinoma (BAC), Any adenocarcinoma in a never-smoker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sunitinib
Other Intervention Name(s)
SU011248
Intervention Description
50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
Primary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
January 2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard West, M.D.
Organizational Affiliation
Swedish Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma
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