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

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Perifosine
Capecitabine
Perifosine Placebo
Sponsored by
AEterna Zentaris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Capecitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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/ฮผL
    • absolute neutrophil count >= 1,500/ ฮผL
    • platelets >= 100,000/ ฮผL
    • 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.

Sites / Locations

  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site
  • AOI Pharmaceuticals Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1: Perifosine + Capecitabine

Arm 2: Perifosine Placebo + Capecitabine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effects of perifosine on time to progression
Time to progression will be measured from the first day of study drug until progression.

Secondary Outcome Measures

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

Full Information

First Posted
November 6, 2006
Last Updated
March 12, 2018
Sponsor
AEterna Zentaris
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1. Study Identification

Unique Protocol Identification Number
NCT00398879
Brief Title
Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients
Official Title
A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AEterna Zentaris

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Perifosine + Capecitabine
Arm Type
Experimental
Arm Description
Perifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Arm Title
Arm 2: Perifosine Placebo + Capecitabine
Arm Type
Placebo Comparator
Arm Description
Perifosine Placebo 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Intervention Type
Drug
Intervention Name(s)
Perifosine
Other Intervention Name(s)
D-21266, KRX-0401
Intervention Description
Perifosine 50 mg/d qd
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks
Intervention Type
Other
Intervention Name(s)
Perifosine Placebo
Other Intervention Name(s)
placebo
Intervention Description
Placebo to Perifosine 50 mg/d qd
Primary Outcome Measure Information:
Title
Effects of perifosine on time to progression
Description
Time to progression will be measured from the first day of study drug until progression.
Time Frame
Every 12 weeks
Secondary Outcome Measure Information:
Title
Toxicity
Description
Determination of the toxicity of single agent chemotherapy in combination with perifosine. Toxicity evaluation is to be performed throughout the study.
Time Frame
Every 12 weeks
Title
Comparison of time to progression to historical experience
Description
To compare the time to progression of chemotherapy in combination with placebo to historical experience.
Time Frame
Every 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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/ฮผL absolute neutrophil count >= 1,500/ ฮผL platelets >= 100,000/ ฮผL 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Henderson, MD
Organizational Affiliation
Online Collaborative Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
AOI Pharmaceuticals Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Deer Park
State/Province
California
ZIP/Postal Code
94574
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Soquel
State/Province
California
ZIP/Postal Code
95703
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Sebastian
State/Province
Florida
ZIP/Postal Code
32958
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Branson
State/Province
Missouri
ZIP/Postal Code
65616
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59103
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Armonk
State/Province
New York
ZIP/Postal Code
10504
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
AOI Pharmaceuticals Investigative Site
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54915
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21969495
Citation
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.
Results Reference
result

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

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