Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Lung Cancer

• Registration Number: NCT00953459
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2010-07
• Study Completion: 2012-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-25
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

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