Clinical trial NCT01097018: Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: AEterna Zentaris
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Overall Survival
timeFrame: Monthly
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Every 6 weeks
Other outcomes:
Locations:
city: Alhambra
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: La Verne
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Northridge
country: United States
state: California
city: Redondo Beach
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Grand Junction
country: United States
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Stamford
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Fort Myers
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Athens
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Lawrenceville
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Harvey
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Terre Haute
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Lansing
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Morristown
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Armonk
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York City
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Bismark
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Columbia
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
facility: TN Oncology
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Johanna Bendell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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