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Colon CancerPhase 2NCT00398879

Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients

A Phase 2 study testing Perifosine and Capecitabine in people with Colon Cancer, run by AEterna Zentaris at 49 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

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer
What is being tested?
Perifosine and Capecitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
381 participants
Where
49 sitesUnited States
Study dates
Aug 2005to Oct 2011
Phase
Phase 2
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

  • In the opinion of the treating physician, treatment with one of the following regimens should represent an appropriate treatment for the patient.
  • Capecitabine 825 mg/m2 BID days 1 - 14 q 3 weeks
  • Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.
  • Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.
  • ECOG performance status 0 or 1.
  • Leukocytes >= 4,000/μL
Show all 15Show fewer
  • absolute neutrophil count >= 1,500/ μL
  • platelets >= 100,000/ μL
  • HCT > 28% (with or without growth factor support)
  • Creatinine <= 2.5 mg/dl
  • total bilirubin < 1.5 x upper limit of normal
  • transaminase < 2.5 x upper limit of normal
  • Patients must have recovered from acute toxicity-excluding alopecia-related to prior therapy, including surgery or radiotherapy.
  • Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.
  • Patients must have ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients receiving any other investigational agents or devices.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study due to potential pharmacokinetic interactions with perifosine.
  • Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Assoc. class II - IV congestive heart failure.
  • Female patients who are pregnant or lactating are ineligible.

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • AOI Pharmaceuticals Investigative Site

    Albany, New York, 12208

  • AOI Pharmaceuticals Investigative Site

    Appleton, Wisconsin, 54915

  • AOI Pharmaceuticals Investigative Site

    Armonk, New York, 10504

  • AOI Pharmaceuticals Investigative Site

    Augusta, Georgia, 30904

  • AOI Pharmaceuticals Investigative Site

    Aventura, Florida, 33180

  • AOI Pharmaceuticals Investigative Site

    Beverly Hills, California, 90211

  • AOI Pharmaceuticals Investigative Site

    Billings, Montana, 59103

  • AOI Pharmaceuticals Investigative Site

    Branson, Missouri, 65616

  • AOI Pharmaceuticals Investigative Site

    Chattanooga, Tennessee, 37404

  • AOI Pharmaceuticals Investigative Site

    Chesapeake, Virginia, 23320

  • AOI Pharmaceuticals Investigative Site

    Colorado Springs, Colorado, 80909

  • AOI Pharmaceuticals Investigative Site

    Coral Springs, Florida, 33065

  • AOI Pharmaceuticals Investigative Site

    Dallas, Texas, 75231

  • AOI Pharmaceuticals Investigative Site

    Dallas, Texas, 75246

  • AOI Pharmaceuticals Investigative Site

    Dayton, Ohio, 45409

  • AOI Pharmaceuticals Investigative Site

    Deer Park, California, 94574

  • AOI Pharmaceuticals Investigative Site

    Galesburg, Illinois, 61401

  • AOI Pharmaceuticals Investigative Site

    Grand Rapids, Michigan, 49546

  • AOI Pharmaceuticals Investigative Site

    Great Falls, Montana, 59405

  • AOI Pharmaceuticals Investigative Site

    Great Neck, New York, 11042

  • AOI Pharmaceuticals Investigative Site

    Greeley, Colorado, 80631

  • AOI Pharmaceuticals Investigative Site

    Greenville, South Carolina, 29605

  • AOI Pharmaceuticals Investigative Site

    Kalamazoo, Michigan, 49048

  • AOI Pharmaceuticals Investigative Site

    Lafayette, Louisiana, 70506

  • AOI Pharmaceuticals Investigative Site

    Lake City, Florida, 32055

  • AOI Pharmaceuticals Investigative Site

    Lawrenceville, Georgia, 30045

  • AOI Pharmaceuticals Investigative Site

    Louisville, Kentucky, 40202

  • AOI Pharmaceuticals Investigative Site

    Marietta, Georgia, 30060

  • AOI Pharmaceuticals Investigative Site

    Memphis, Tennessee, 38120

  • AOI Pharmaceuticals Investigative Site

    Miami, Florida, 33176

  • AOI Pharmaceuticals Investigative Site

    Middletown, Connecticut, 06457

  • AOI Pharmaceuticals Investigative Site

    Monterey, California, 93940

  • AOI Pharmaceuticals Investigative Site

    Newport Beach, California, 92663

  • AOI Pharmaceuticals Investigative Site

    Norfolk, Virginia, 23502

  • AOI Pharmaceuticals Investigative Site

    Norwich, Connecticut, 06360

  • AOI Pharmaceuticals Investigative Site

    Ormond Beach, Florida, 32174

  • AOI Pharmaceuticals Investigative Site

    Park Ridge, Illinois, 60068

  • AOI Pharmaceuticals Investigative Site

    Pomona, California, 91767

  • AOI Pharmaceuticals Investigative Site

    Pottsville, Pennsylvania, 17901

  • AOI Pharmaceuticals Investigative Site

    Santa Rosa, California, 95403

  • AOI Pharmaceuticals Investigative Site

    Sayre, Pennsylvania, 18840

  • AOI Pharmaceuticals Investigative Site

    Sebastian, Florida, 32958

  • AOI Pharmaceuticals Investigative Site

    Soquel, California, 95703

  • AOI Pharmaceuticals Investigative Site

    Spokane, Washington, 99218

  • AOI Pharmaceuticals Investigative Site

    Stockton, California, 95207

  • AOI Pharmaceuticals Investigative Site

    Tucson, Arizona, 85704

  • AOI Pharmaceuticals Investigative Site

    Tyler, Texas, 75702

  • AOI Pharmaceuticals Investigative Site

    Vero Beach, Florida, 32960

  • AOI Pharmaceuticals Investigative Site

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone.

The effects of perifosine may be manifested by increased time to progression, tumor regression reflected in partial or complete responses, or a combination of these outcomes. The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression.

Read the detailed description

This is an exploratory phase 2, randomized placebo-controlled trial with stratification for disease and chemotherapy type. If there is any evidence of improved time to progression in any tumor type with any of the drugs to be evaluated, the initial study or component(s) of the study will be expanded to increase the certainty that this is an effect of perifosine. If there is compelling evidence of benefit from this study, a phase 3 trial will be conducted to obtain proof of principle.

Primary Study Objectives:

To determine the time to tumor progression when receiving single agent chemotherapy (capecitabine) in combination with perifosine in comparison to patients receiving single agent chemotherapy (capecitabine) alone (i.e., with placebo).

Secondary Study Objectives:

  • To determine the toxicity of single agent chemotherapy in combination with perifosine.
  • To compare the time to progression of chemotherapy in combination with placebo to historical experience.
  • Overall survival will also be evaluated.
Conditions
Colon Cancer
Being tested
Perifosine, Capecitabine, Perifosine Placebo
Keywords
Capecitabine
Medical subject headings
Colonic Neoplasms

What participants receive

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

  • PerifosineDrug

    Also called D-21266, KRX-0401

    Perifosine 50 mg/d qd

  • CapecitabineDrug

    Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks

  • Perifosine PlaceboOther

    Also called placebo

    Placebo to Perifosine 50 mg/d qd

Study groups in NCT00398879
Study groupRoleWhat they receive
Arm 1: Perifosine + CapecitabineExperimentalPerifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Receives: Drug: Perifosine; Drug: Capecitabine
Arm 2: Perifosine Placebo + CapecitabinePlacebo comparatorPerifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Receives: Drug: Capecitabine; Other: Perifosine Placebo

What is being measured

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

  1. Effects of perifosine on time to progression

    Time to progression will be measured from the first day of study drug until progression.

    Measured: Every 12 weeks

Secondary outcomes (2)

  1. Toxicity

    Determination of the toxicity of single agent chemotherapy in combination with perifosine. Toxicity evaluation is to be performed throughout the study.

    Measured: Every 12 weeks

  2. Comparison of time to progression to historical experience

    To compare the time to progression of chemotherapy in combination with placebo to historical experience.

    Measured: Every 12 weeks

Timeline

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

  1. First posted14 Nov 2006 (estimated)
  2. Study startAug 2005
  3. Primary completionDec 2010
  4. Study completionOct 2011

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398879
Sponsor's protocol ID
Perifosine 211
Status last verified
Feb 2012
First submitted
6 Nov 2006
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Bendell JC, Nemunaitis J, Vukelja SJ, Hagenstad C, Campos LT, Hermann RC, Sportelli P, Gardner L, Richards DA. Randomized placebo-controlled phase II trial of perifosine plus capecitabine as second- or third-line therapy in patients with metastatic colorectal cancer. J Clin Oncol. 2011 Nov 20;29(33):4394-400. doi: 10.1200/JCO.2011.36.1980. Epub 2011 Oct 3.

    PubMed 21969495

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Perifosine and Capecitabine in people with Colon Cancer, run by AEterna Zentaris at 49 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 15 inclusion and 6 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Effects of perifosine on time to progression (time frame: Every 12 weeks). 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 NCT00398879, 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 14 Mar 2018.

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