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

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ClinicalTrials.gov Identifier: NCT00398879
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Perifosine Drug: Capecitabine Other: Perifosine Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients
Study Start Date : August 2005
Actual Primary Completion Date : December 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Perifosine + Capecitabine
Perifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Drug: Perifosine
Perifosine 50 mg/d qd
Other Names:
  • D-21266
  • KRX-0401

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

Placebo Comparator: Arm 2: Perifosine Placebo + Capecitabine
Perifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Drug: Capecitabine
Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks

Other: Perifosine Placebo
Placebo to Perifosine 50 mg/d qd
Other Name: placebo




Primary Outcome Measures :
  1. Effects of perifosine on time to progression [ Time Frame: Every 12 weeks ]
    Time to progression will be measured from the first day of study drug until progression.


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: Every 12 weeks ]
    Determination of the toxicity of single agent chemotherapy in combination with perifosine. Toxicity evaluation is to be performed throughout the study.

  2. Comparison of time to progression to historical experience [ Time Frame: Every 12 weeks ]
    To compare the time to progression of chemotherapy in combination with placebo to historical experience.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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

  2. Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.
  3. Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.
  4. ECOG performance status 0 or 1.

    • Leukocytes >= 4,000/μL
    • 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
  5. Patients must have recovered from acute toxicity—excluding alopecia—related to prior therapy, including surgery or radiotherapy.
  6. Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.
  7. Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients receiving any other investigational agents or devices.
  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements.
  4. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study due to potential pharmacokinetic interactions with perifosine.
  5. 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.
  6. Female patients who are pregnant or lactating are ineligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398879


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Locations
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United States, Arizona
AOI Pharmaceuticals Investigative Site
Tucson, Arizona, United States, 85704
United States, California
AOI Pharmaceuticals Investigative Site
Beverly Hills, California, United States, 90211
AOI Pharmaceuticals Investigative Site
Deer Park, California, United States, 94574
AOI Pharmaceuticals Investigative Site
Monterey, California, United States, 93940
AOI Pharmaceuticals Investigative Site
Newport Beach, California, United States, 92663
AOI Pharmaceuticals Investigative Site
Pomona, California, United States, 91767
AOI Pharmaceuticals Investigative Site
Santa Rosa, California, United States, 95403
AOI Pharmaceuticals Investigative Site
Soquel, California, United States, 95703
AOI Pharmaceuticals Investigative Site
Stockton, California, United States, 95207
United States, Colorado
AOI Pharmaceuticals Investigative Site
Colorado Springs, Colorado, United States, 80909
AOI Pharmaceuticals Investigative Site
Greeley, Colorado, United States, 80631
United States, Connecticut
AOI Pharmaceuticals Investigative Site
Middletown, Connecticut, United States, 06457
AOI Pharmaceuticals Investigative Site
Norwich, Connecticut, United States, 06360
United States, Florida
AOI Pharmaceuticals Investigative Site
Aventura, Florida, United States, 33180
AOI Pharmaceuticals Investigative Site
Coral Springs, Florida, United States, 33065
AOI Pharmaceuticals Investigative Site
Lake City, Florida, United States, 32055
AOI Pharmaceuticals Investigative Site
Miami, Florida, United States, 33176
AOI Pharmaceuticals Investigative Site
Ormond Beach, Florida, United States, 32174
AOI Pharmaceuticals Investigative Site
Sebastian, Florida, United States, 32958
AOI Pharmaceuticals Investigative Site
Vero Beach, Florida, United States, 32960
United States, Georgia
AOI Pharmaceuticals Investigative Site
Augusta, Georgia, United States, 30904
AOI Pharmaceuticals Investigative Site
Lawrenceville, Georgia, United States, 30045
AOI Pharmaceuticals Investigative Site
Marietta, Georgia, United States, 30060
United States, Illinois
AOI Pharmaceuticals Investigative Site
Galesburg, Illinois, United States, 61401
AOI Pharmaceuticals Investigative Site
Park Ridge, Illinois, United States, 60068
United States, Kentucky
AOI Pharmaceuticals Investigative Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
AOI Pharmaceuticals Investigative Site
Lafayette, Louisiana, United States, 70506
United States, Michigan
AOI Pharmaceuticals Investigative Site
Grand Rapids, Michigan, United States, 49546
AOI Pharmaceuticals Investigative Site
Kalamazoo, Michigan, United States, 49048
United States, Missouri
AOI Pharmaceuticals Investigative Site
Branson, Missouri, United States, 65616
United States, Montana
AOI Pharmaceuticals Investigative Site
Billings, Montana, United States, 59103
AOI Pharmaceuticals Investigative Site
Great Falls, Montana, United States, 59405
United States, New York
AOI Pharmaceuticals Investigative Site
Albany, New York, United States, 12208
AOI Pharmaceuticals Investigative Site
Armonk, New York, United States, 10504
AOI Pharmaceuticals Investigative Site
Great Neck, New York, United States, 11042
United States, North Carolina
AOI Pharmaceuticals Investigative Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
AOI Pharmaceuticals Investigative Site
Dayton, Ohio, United States, 45409
United States, Pennsylvania
AOI Pharmaceuticals Investigative Site
Pottsville, Pennsylvania, United States, 17901
AOI Pharmaceuticals Investigative Site
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
AOI Pharmaceuticals Investigative Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
AOI Pharmaceuticals Investigative Site
Chattanooga, Tennessee, United States, 37404
AOI Pharmaceuticals Investigative Site
Memphis, Tennessee, United States, 38120
United States, Texas
AOI Pharmaceuticals Investigative Site
Dallas, Texas, United States, 75231
AOI Pharmaceuticals Investigative Site
Dallas, Texas, United States, 75246
AOI Pharmaceuticals Investigative Site
Tyler, Texas, United States, 75702
United States, Virginia
AOI Pharmaceuticals Investigative Site
Chesapeake, Virginia, United States, 23320
AOI Pharmaceuticals Investigative Site
Norfolk, Virginia, United States, 23502
United States, Washington
AOI Pharmaceuticals Investigative Site
Spokane, Washington, United States, 99218
United States, Wisconsin
AOI Pharmaceuticals Investigative Site
Appleton, Wisconsin, United States, 54915
Sponsors and Collaborators
AEterna Zentaris
Investigators
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Study Chair: Craig Henderson, MD Online Collaborative Oncology Group

Publications of Results:
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Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00398879     History of Changes
Other Study ID Numbers: Perifosine 211
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: February 2012
Keywords provided by AEterna Zentaris:
Capecitabine
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents