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

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ClinicalTrials.gov Identifier: NCT00430261
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : October 6, 2010
Sponsor:
Collaborator:
Information provided by:

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  (Clinical Trial)
Estimated 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 : January 2007
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: sunitinib
    50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
    Other Name: SU011248

Outcome Measures

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: January 2009 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430261


Locations
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Pfizer
Investigators
Principal Investigator: Howard West, M.D. Swedish Cancer Institute
More Information

Additional Information:
Responsible Party: Howard jack West, M.D., Swedish Medical Center, Swedish Cancer Institute
ClinicalTrials.gov Identifier: NCT00430261     History of Changes
Other Study ID Numbers: CRC 05160
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: October 6, 2010
Last Verified: October 2010

Keywords provided by Swedish Medical Center:
bronchoalveolar carcinoma
BAC
adenocarcinoma
lung cancer
oral
Stage IIIB and IV lung cancer
Any bronchoalveolar carcinoma (BAC)
Any adenocarcinoma in a never-smoker

Additional relevant MeSH terms:
Lung Neoplasms
Adenocarcinoma
Adenocarcinoma, Bronchiolo-Alveolar
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors