Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer (X-PECT)

A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Perifosine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Alhambra, California, United States, 91801
    • Bakersfield, California, United States, 93309
    • La Verne, California, United States, 91750
    • Long Beach, California, United States, 90813
    • Los Angeles, California, United States, 90095
    • Northridge, California, United States, 91325
    • Redondo Beach, California, United States, 90277
    • Santa Barbara, California, United States, 93105
    • Santa Maria, California, United States, 93454
  • Colorado
    • Denver, Colorado, United States, 80218
    • Grand Junction, Colorado, United States, 81501
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
    • Stamford, Connecticut, United States, 06902
    • Waterbury, Connecticut, United States, 06708
  • Florida
    • Fort Myers, Florida, United States, 33916
    • Hollywood, Florida, United States, 33021
    • Pembroke Pines, Florida, United States, 33028
  • Georgia
    • Athens, Georgia, United States, 30607
    • Atlanta, Georgia, United States, 30341
    • Lawrenceville, Georgia, United States, 30046
    • Marietta, Georgia, United States, 30060
    • Roswell, Georgia, United States, 30076
  • Illinois
    • Harvey, Illinois, United States, 60467
    • Park Ridge, Illinois, United States, 60068
  • Indiana
    • South Bend, Indiana, United States, 44601
    • Terre Haute, Indiana, United States, 47802
  • Maryland
    • Baltimore, Maryland, United States, 21287
    • Bethesda, Maryland, United States, 20817
  • Michigan
    • Lansing, Michigan, United States, 48912
  • Mississippi
    • Jackson, Mississippi, United States, 39202
    • Tupelo, Mississippi, United States, 38801
  • Missouri
    • St. Louis, Missouri, United States, 63110
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
  • Nevada
    • Henderson, Nevada, United States, 89052
    • Las Vegas, Nevada, United States, 89169
  • New Jersey
    • Morristown, New Jersey, United States, 07960
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
    • Albuquerque, New Mexico, United States, 87110
  • New York
    • Armonk, New York, United States, 10504
    • Great Neck, New York, United States, 11042
    • New Hyde Park, New York, United States, 11040
    • New York City, New York, United States, 10016
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
  • North Dakota
    • Bismark, North Dakota, United States, 58504
    • Fargo, North Dakota, United States, 58122
  • Ohio
    • Cincinnati, Ohio, United States, 45242
    • Columbus, Ohio, United States, 43210
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • South Carolina
    • Columbia, South Carolina, United States, 29210
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
    • Memphis, Tennessee, United States, 38120
    • Nashville, Tennessee, United States, 37203
      • TN Oncology
  • Texas
    • Abilene, Texas, United States, 79606
    • Austin, Texas, United States, 78731
    • Beaumont, Texas, United States, 77702
    • Dallas, Texas, United States, 75246
    • Dallas, Texas, United States, 75231
    • Dallas, Texas, United States, 75230
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77030
    • Midland, Texas, United States, 79701
    • Tyler, Texas, United States, 75702
  • Virginia
    • Richmond, Virginia, United States, 23230
  • Washington
    • Seattle, Washington, United States, 98104
    • Spokane, Washington, United States, 99208

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Perifosine + Capecitabine; Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days	Drug: Capecitabine; 1000 mg/m2 BID/ Days 1-14; Drug: Perifosine; 50 mg daily x 21 days
Placebo Comparator: Placebo + Capecitabine; Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days	Drug: Capecitabine; 1000 mg/m2 BID/ Days 1-14; Drug: Placebo; 1 pill daily x 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Monthly

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free Survival	Every 6 weeks

Collaborators and Investigators

• Sponsor: AEterna Zentaris

Publications and helpful links

General Publications

• Results of the X-PECT study: A phase III randomized double-blind, placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC). https://meetinglibrary.asco.org/content/98646-114 Abstract Number:LBA3501

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (Estimate): April 1, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: Protocol 343