Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00953459
- Brief Summary
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer.
Secondary
* To characterize the safety of sunitinib malate in these patients.
Tertiary
* To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (chemonaïve extensive stage vs sensitive relapse at least 3 months after stopping chemotherapy).
Patients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron emission tomography of the chest at week 4. Blood samples and bronchial washings and brushings may be collected at baseline and at 4 and 8 weeks after start of therapy for further analysis.
After completion of study treatment, patients are followed up every 3 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria
- Secondary Outcome Measures
Name Time Method Response rate every 4 weeks according to RECIST criteria Duration of progression-free survival Duration of response Duration of survival Toxicity according to NCI CTCAE version 3.0 Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response
Trial Locations
- Locations (1)
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Vrije Universiteit Medisch Centrum🇳🇱Amsterdam, Netherlands