Trial record 1 of 3 for:    perifosine colorectal
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Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer (X-PECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01097018
First received: March 30, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Drug: Capecitabine
Drug: Perifosine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 468
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097018

  Hide Study Locations
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
United States, Colorado
Denver, Colorado, United States, 80218
Grand Junction, Colorado, United States, 81501
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Stamford, Connecticut, United States, 06902
Waterbury, Connecticut, United States, 06708
United States, Florida
Fort Myers, Florida, United States, 33916
Hollywood, Florida, United States, 33021
Pembroke Pines, Florida, United States, 33028
United States, 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
United States, Illinois
Harvey, Illinois, United States, 60467
Park Ridge, Illinois, United States, 60068
United States, Indiana
South Bend, Indiana, United States, 44601
Terre Haute, Indiana, United States, 47802
United States, Maryland
Baltimore, Maryland, United States, 21287
Bethesda, Maryland, United States, 20817
United States, Michigan
Lansing, Michigan, United States, 48912
United States, Mississippi
Jackson, Mississippi, United States, 39202
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Nebraska
Lincoln, Nebraska, United States, 68510
United States, Nevada
Henderson, Nevada, United States, 89052
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Morristown, New Jersey, United States, 07960
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
Albuquerque, New Mexico, United States, 87110
United States, 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
United States, North Carolina
Charlotte, North Carolina, United States, 28204
United States, North Dakota
Bismark, North Dakota, United States, 58504
Fargo, North Dakota, United States, 58122
United States, Ohio
Cincinnati, Ohio, United States, 45242
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Memphis, Tennessee, United States, 38120
TN Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
Abilene, Texas, United States, 79606
Austin, Texas, United States, 78731
Beaumont, Texas, United States, 77702
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75231
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77030
Midland, Texas, United States, 79701
Tyler, Texas, United States, 75702
United States, Virginia
Richmond, Virginia, United States, 23230
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99208
Sponsors and Collaborators
AEterna Zentaris
Investigators
Principal Investigator: Johanna Bendell, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01097018     History of Changes
Other Study ID Numbers: Protocol 343
Study First Received: March 30, 2010
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014