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

NCT01097018 — Phase 3, Completed, 468 participants, AEterna Zentaris
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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

RegistryNCT01097018, acronym X-PECT
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment468 (Actual)
SponsorAEterna Zentaris (Industry)
ConditionsColorectal Cancer
InterventionsCapecitabine, Perifosine, Placebo (Drug)
Datesstart 2010-04-01, primary completion 2012-04-01, completion 2012-04-01, first posted 2010-04-01, last updated 2013-07-02
Locations65 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Colorectal Cancer All trials of Capecitabine All trials of Perifosine

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Perifosine + CapecitabineActive comparatorDrug: Capecitabine; Drug: PerifosinePerifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Placebo + CapecitabinePlacebo comparatorDrug: Capecitabine; Drug: PlaceboPlacebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
  • Capecitabine (Drug): 1000 mg/m2 BID/ Days 1-14
  • Perifosine (Drug): 50 mg daily x 21 days
  • Placebo (Drug): 1 pill daily x 21 days

+Outcome measures

Primary outcomes

  • Overall Survival [Monthly]

Secondary outcomes

  • Progression-free Survival [Every 6 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (65)

FacilityCityCountryStatus
Alhambra, CaliforniaUnited States
Bakersfield, CaliforniaUnited States
La Verne, CaliforniaUnited States
Long Beach, CaliforniaUnited States
Los Angeles, CaliforniaUnited States
Northridge, CaliforniaUnited States
Redondo Beach, CaliforniaUnited States
Santa Barbara, CaliforniaUnited States
Santa Maria, CaliforniaUnited States
Denver, ColoradoUnited States
Grand Junction, ColoradoUnited States
Yale University School of MedicineNew Haven, ConnecticutUnited States
Stamford, ConnecticutUnited States
Waterbury, ConnecticutUnited States
Fort Myers, FloridaUnited States
Hollywood, FloridaUnited States
Pembroke Pines, FloridaUnited States
Athens, GeorgiaUnited States
Atlanta, GeorgiaUnited States
Lawrenceville, GeorgiaUnited States
Marietta, GeorgiaUnited States
Roswell, GeorgiaUnited States
Harvey, IllinoisUnited States
Park Ridge, IllinoisUnited States
South Bend, IndianaUnited States
Terre Haute, IndianaUnited States
Baltimore, MarylandUnited States
Bethesda, MarylandUnited States
Lansing, MichiganUnited States
Jackson, MississippiUnited States
Tupelo, MississippiUnited States
St Louis, MissouriUnited States
Lincoln, NebraskaUnited States
Henderson, NevadaUnited States
Las Vegas, NevadaUnited States
Morristown, New JerseyUnited States
Albuquerque, New MexicoUnited States
Albuquerque, New MexicoUnited States
Armonk, New YorkUnited States
Great Neck, New YorkUnited States
New Hyde Park, New YorkUnited States
New York, New YorkUnited States
Charlotte, North CarolinaUnited States
Bismarck, North DakotaUnited States
Fargo, North DakotaUnited States
Cincinnati, OhioUnited States
Columbus, OhioUnited States
Oklahoma City, OklahomaUnited States
Columbia, South CarolinaUnited States
Chattanooga, TennesseeUnited States
Memphis, TennesseeUnited States
TN OncologyNashville, TennesseeUnited States
Abilene, TexasUnited States
Austin, TexasUnited States
Beaumont, TexasUnited States
Dallas, TexasUnited States
Dallas, TexasUnited States
Dallas, TexasUnited States
Fort Worth, TexasUnited States
Houston, TexasUnited States
Midland, TexasUnited States
Tyler, TexasUnited States
Richmond, VirginiaUnited States
Seattle, WashingtonUnited States
Spokane, WashingtonUnited States

+Publications

  • Results publication: 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

+Investigators