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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

Tracking Information
First Submitted Date  ICMJE November 6, 2006
First Posted Date  ICMJE November 14, 2006
Last Update Posted Date March 14, 2018
Study Start Date  ICMJE August 2005
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2006)
To determine the proportion of patients progression free at 6 months.
Change History Complete list of historical versions of study NCT00398879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients
Official Title  ICMJE A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • 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
  • Other: Perifosine Placebo
    Placebo to Perifosine 50 mg/d qd
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Arm 1: Perifosine + Capecitabine
    Perifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
    Interventions:
    • Drug: Perifosine
    • Drug: Capecitabine
  • 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
    Interventions:
    • Drug: Capecitabine
    • Other: Perifosine Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2011)
381
Original Enrollment  ICMJE
 (submitted: November 10, 2006)
100
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00398879
Other Study ID Numbers  ICMJE Perifosine 211
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AEterna Zentaris
Study Sponsor  ICMJE AEterna Zentaris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Craig Henderson, MD Online Collaborative Oncology Group
PRS Account AEterna Zentaris
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP