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

Sponsor
AEterna Zentaris (Industry)
Overall Status
Completed
CT.gov ID
NCT00398879
Collaborator
(none)
381
Enrollment
49
Locations
2
Arms
74
Duration (Months)
7.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Aug 1, 2005
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

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 Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effects of perifosine on time to progression [Every 12 weeks]

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

    Secondary Outcome Measures

    1. Toxicity [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 [Every 12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Patients should have a histologically or cytologically confirmed diagnosis of colorectal cancer.

    2. Patients must have received at least one but no more than two prior chemotherapy regimen(s) for the treatment of metastatic or recurrent disease.

    3. 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

    1. Patients must have recovered from acute toxicity-excluding alopecia-related to prior therapy, including surgery or radiotherapy.

    2. Patients with brain metastases may be admitted, provided the disease has been treated and been stable for 2 months.

    3. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AOI Pharmaceuticals Investigative Site Tucson Arizona United States 85704
    2 AOI Pharmaceuticals Investigative Site Beverly Hills California United States 90211
    3 AOI Pharmaceuticals Investigative Site Deer Park California United States 94574
    4 AOI Pharmaceuticals Investigative Site Monterey California United States 93940
    5 AOI Pharmaceuticals Investigative Site Newport Beach California United States 92663
    6 AOI Pharmaceuticals Investigative Site Pomona California United States 91767
    7 AOI Pharmaceuticals Investigative Site Santa Rosa California United States 95403
    8 AOI Pharmaceuticals Investigative Site Soquel California United States 95703
    9 AOI Pharmaceuticals Investigative Site Stockton California United States 95207
    10 AOI Pharmaceuticals Investigative Site Colorado Springs Colorado United States 80909
    11 AOI Pharmaceuticals Investigative Site Greeley Colorado United States 80631
    12 AOI Pharmaceuticals Investigative Site Middletown Connecticut United States 06457
    13 AOI Pharmaceuticals Investigative Site Norwich Connecticut United States 06360
    14 AOI Pharmaceuticals Investigative Site Aventura Florida United States 33180
    15 AOI Pharmaceuticals Investigative Site Coral Springs Florida United States 33065
    16 AOI Pharmaceuticals Investigative Site Lake City Florida United States 32055
    17 AOI Pharmaceuticals Investigative Site Miami Florida United States 33176
    18 AOI Pharmaceuticals Investigative Site Ormond Beach Florida United States 32174
    19 AOI Pharmaceuticals Investigative Site Sebastian Florida United States 32958
    20 AOI Pharmaceuticals Investigative Site Vero Beach Florida United States 32960
    21 AOI Pharmaceuticals Investigative Site Augusta Georgia United States 30904
    22 AOI Pharmaceuticals Investigative Site Lawrenceville Georgia United States 30045
    23 AOI Pharmaceuticals Investigative Site Marietta Georgia United States 30060
    24 AOI Pharmaceuticals Investigative Site Galesburg Illinois United States 61401
    25 AOI Pharmaceuticals Investigative Site Park Ridge Illinois United States 60068
    26 AOI Pharmaceuticals Investigative Site Louisville Kentucky United States 40202
    27 AOI Pharmaceuticals Investigative Site Lafayette Louisiana United States 70506
    28 AOI Pharmaceuticals Investigative Site Grand Rapids Michigan United States 49546
    29 AOI Pharmaceuticals Investigative Site Kalamazoo Michigan United States 49048
    30 AOI Pharmaceuticals Investigative Site Branson Missouri United States 65616
    31 AOI Pharmaceuticals Investigative Site Billings Montana United States 59103
    32 AOI Pharmaceuticals Investigative Site Great Falls Montana United States 59405
    33 AOI Pharmaceuticals Investigative Site Albany New York United States 12208
    34 AOI Pharmaceuticals Investigative Site Armonk New York United States 10504
    35 AOI Pharmaceuticals Investigative Site Great Neck New York United States 11042
    36 AOI Pharmaceuticals Investigative Site Wilmington North Carolina United States 28401
    37 AOI Pharmaceuticals Investigative Site Dayton Ohio United States 45409
    38 AOI Pharmaceuticals Investigative Site Pottsville Pennsylvania United States 17901
    39 AOI Pharmaceuticals Investigative Site Sayre Pennsylvania United States 18840
    40 AOI Pharmaceuticals Investigative Site Greenville South Carolina United States 29605
    41 AOI Pharmaceuticals Investigative Site Chattanooga Tennessee United States 37404
    42 AOI Pharmaceuticals Investigative Site Memphis Tennessee United States 38120
    43 AOI Pharmaceuticals Investigative Site Dallas Texas United States 75231
    44 AOI Pharmaceuticals Investigative Site Dallas Texas United States 75246
    45 AOI Pharmaceuticals Investigative Site Tyler Texas United States 75702
    46 AOI Pharmaceuticals Investigative Site Chesapeake Virginia United States 23320
    47 AOI Pharmaceuticals Investigative Site Norfolk Virginia United States 23502
    48 AOI Pharmaceuticals Investigative Site Spokane Washington United States 99218
    49 AOI Pharmaceuticals Investigative Site Appleton Wisconsin United States 54915

    Sponsors and Collaborators

    • AEterna Zentaris

    Investigators

    • Study Chair: Craig Henderson, MD, Online Collaborative Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AEterna Zentaris
    ClinicalTrials.gov Identifier:
    NCT00398879
    Other Study ID Numbers:
    • Perifosine 211
    First Posted:
    Nov 14, 2006
    Last Update Posted:
    Mar 14, 2018
    Last Verified:
    Feb 1, 2012
    Keywords provided by AEterna Zentaris
    Capecitabine
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Capecitabine

    Study Results

    No Results Posted as of Mar 14, 2018