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

  Show 65 Study Locations
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 19, 2014