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

NCT00430261

Last updated date
Study Location
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Cancer, Adenocarcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Uncontrolled hypertension


- Unstable brain metastases


- Pregnant/nursing women


- Uncontrolled thyroid disease

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Lung Cancer, AdenocarcinomaPhase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma
NCT00430261
  1. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma
Official Title  ICMJE Phase II Trial of Sunitinib in Bronchoalveolar Carcinoma or Never-Smokers With Any Lung Adenocarcinoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Adenocarcinoma
Intervention  ICMJE Drug: sunitinib
50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
Other Name: SU011248
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 23, 2008)
20
Original Enrollment  ICMJE
 (submitted: January 31, 2007)
10
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00430261
Other Study ID Numbers  ICMJE CRC 05160
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Howard jack West, M.D., Swedish Medical Center, Swedish Cancer Institute
Study Sponsor  ICMJE Swedish Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Howard West, M.D.Swedish Cancer Institute
PRS Account Swedish Medical Center
Verification Date October 2010

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