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
  Purpose

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 Intervention Phase
Lung Cancer
Adenocarcinoma
Drug: sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Sunitinib in Bronchoalveolar Carcinoma or Never-Smokers With Any Lung Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: January 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sunitinib
    50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
    Other Name: SU011248
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: January 30, 2007
Last Updated: October 5, 2010
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014