Adenocarcinoma, Lung Cancer
Conditions
Keywords
bronchoalveolar carcinoma, BAC, adenocarcinoma, lung cancer, oral, Stage IIIB and IV lung cancer, Any bronchoalveolar carcinoma (BAC), Any adenocarcinoma in a never-smoker
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.
Interventions
DRUGsunitinib
50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
Sponsors
Pfizer
Swedish Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival | January 2009 |
Countries
United States
Outcome results
None listed