- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00430261
Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma
October 5, 2010 updated by: Swedish Medical Center
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 Overview
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
-
Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-Free Survival
Time Frame: January 2009
|
January 2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Howard West, M.D., Swedish Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
January 30, 2007
First Submitted That Met QC Criteria
January 31, 2007
First Posted (Estimate)
February 1, 2007
Study Record Updates
Last Update Posted (Estimate)
October 6, 2010
Last Update Submitted That Met QC Criteria
October 5, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenocarcinoma
- Adenocarcinoma of Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- CRC 05160
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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