Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00953459
Study type	Interventional
Source	European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status	Terminated
Phase	Phase 2
Start date	February 2009
Completion date	September 2012

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