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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00430261
First received: January 30, 2007
Last updated: October 5, 2010
Last verified: October 2010

January 30, 2007
October 5, 2010
January 2007
October 2010   (final data collection date for primary outcome measure)
Progression-Free Survival [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Progression-Free Survival
  • Time to Progression
Complete list of historical versions of study NCT00430261 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Cancer
  • Adenocarcinoma
Drug: sunitinib
50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
Other Name: SU011248
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00430261
CRC 05160
No
Howard jack West, M.D., Swedish Medical Center, Swedish Cancer Institute
Swedish Medical Center
Pfizer
Principal Investigator: Howard West, M.D. Swedish Cancer Institute
Swedish Medical Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP