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

Swedish Medical Center

Status and phase: Completed; Phase 2

Conditions: Lung Cancer; Adenocarcinoma

Treatments: Drug: sunitinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00430261

CRC 05160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)