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Colorectal CancerPhase 3X-PECTNCT01097018

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

A Phase 3 study testing Capecitabine and Perifosine in people with Colorectal Cancer, run by AEterna Zentaris at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Capecitabine and Perifosine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
468 participants
Where
65 sitesUnited States
Study dates
Apr 2010to Apr 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Study site

    Abilene, Texas, 79606

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Albuquerque, New Mexico, 87110

  • Study site

    Alhambra, California, 91801

  • Study site

    Armonk, New York, 10504

  • Study site

    Athens, Georgia, 30607

  • Study site

    Atlanta, Georgia, 30341

  • Study site

    Austin, Texas, 78731

  • Study site

    Bakersfield, California, 93309

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Beaumont, Texas, 77702

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Bismarck, North Dakota, 58504

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Columbia, South Carolina, 29210

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75246

  • Study site

    Denver, Colorado, 80218

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Grand Junction, Colorado, 81501

  • Study site

    Great Neck, New York, 11042

  • Study site

    Harvey, Illinois, 60467

  • Study site

    Henderson, Nevada, 89052

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77030

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    La Verne, California, 91750

  • Study site

    Lansing, Michigan, 48912

  • Study site

    Las Vegas, Nevada, 89169

  • Study site

    Lawrenceville, Georgia, 30046

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Long Beach, California, 90813

  • Study site

    Los Angeles, California, 90095

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Midland, Texas, 79701

  • Study site

    Morristown, New Jersey, 07960

  • TN Oncology

    Nashville, Tennessee, 37203

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Study site

    New Hyde Park, New York, 11040

  • Study site

    New York, New York, 10016

  • Study site

    Northridge, California, 91325

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Park Ridge, Illinois, 60068

  • Study site

    Pembroke Pines, Florida, 33028

  • Study site

    Redondo Beach, California, 90277

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Roswell, Georgia, 30076

  • Study site

    Santa Barbara, California, 93105

  • Study site

    Santa Maria, California, 93454

  • Study site

    Seattle, Washington, 98104

  • Study site

    South Bend, Indiana, 44601

  • Study site

    Spokane, Washington, 99208

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stamford, Connecticut, 06902

  • Study site

    Terre Haute, Indiana, 47802

  • Study site

    Tupelo, Mississippi, 38801

  • Study site

    Tyler, Texas, 75702

  • Study site

    Waterbury, Connecticut, 06708

Other trials in United States

About this study

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

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

Being tested
Capecitabine, Perifosine, Placebo
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    1000 mg/m2 BID/ Days 1-14

  • PerifosineDrug

    50 mg daily x 21 days

  • PlaceboDrug

    1 pill daily x 21 days

Study groups in NCT01097018
Study groupRoleWhat they receive
Perifosine + CapecitabineActive comparatorPerifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Receives: Drug: Capecitabine; Drug: Perifosine
Placebo + CapecitabinePlacebo comparatorPlacebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days
Receives: Drug: Capecitabine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: Monthly

Secondary outcomes (1)

  1. Progression-free Survival

    Measured: Every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
468 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01097018
Sponsor's protocol ID
Protocol 343
Acronym
X-PECT
Status last verified
Jun 2013
First submitted
30 Mar 2010
Last updated
2 Jul 2013
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine and Perifosine in people with Colorectal Cancer, run by AEterna Zentaris at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Monthly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01097018, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.

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