Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma

Phase 2

Completed

• Conditions: Advanced Malignant Mesothelioma; Recurrent Malignant Mesothelioma
• Interventions: Drug: sunitinib malate

• Registration Number: NCT00392444
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

This phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

Detailed Description

PRIMARY OBJECTIVES:

I. Assess the efficacy of sunitinib malate, in terms of response rate (complete and partial), in patients with malignant pleural mesothelioma.

II. Assess the toxicity, safety, and tolerability of this drug in these patients.

III. Assess the duration of response or stable disease, stable disease rate, progression-free survival, and median and overall survival rates.

OUTLINE: This is a multicenter, nonrandomized, open-label study. Patients are stratified according to prior cytotoxic chemotherapy (yes vs no).

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Study Timeline

• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Study Start: 2007-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-04
• Results First Submitted: 2013-10-21
• Results First Submitted QC: 2013-10-21
• Results First Posted: 2013-12-13
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (sunitinib malate)	sunitinib malate	Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective Response (Partial and Complete) Per RECIST	Up to 3 years	Number of patients who had objective responses after radiology review

Trial Locations

Locations (1)

National Cancer Institute of Canada Clinical Trials Group; 🇨🇦 Kingston, Ontario, Canada