Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Capecitabine; Drug: Placebo; Drug: Perifosine

• Registration Number: NCT01097018
• Lead Sponsor: AEterna Zentaris

Brief Summary

The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study Start: 2010-04
• Study First Posted: 2010-04-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-06
• Disposition First Submitted: 2013-06-18
• Disposition First Submitted QC: 2013-06-18
• Last Update Submitted: 2013-06-25
• Disposition First Posted: 2013-06-26
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

• Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies.
• For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.
• No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine
• Patients must have at least one measurable lesion by RECIST criteria

Exclusion Criteria

• Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Capecitabine	Placebo	Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Perifosine + Capecitabine	Capecitabine	Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Perifosine + Capecitabine	Perifosine	Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Placebo + Capecitabine	Capecitabine	Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days

Primary Outcome Measures

Name	Time	Method
Overall Survival	Monthly

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	Every 6 weeks

Trial Locations

Locations (2)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

TN Oncology; 🇺🇸 Nashville, Tennessee, United States