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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430261
• Other study ID #: CRC 05160
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2007
• Last updated: October 5, 2010
• Start date: January 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Bronchiolo-Alveolar
• Lung Cancer

Intervention

Drug:
• sunitinib
50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.

Locations

Country	Name	City	State
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Swedish Medical Center	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival		January 2009	No

External Links

•   Swedish Cancer Institute website