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

NCT ID: NCT00398879

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1: Perifosine + Capecitabine

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

Group Type EXPERIMENTAL

Perifosine

Intervention Type DRUG

Perifosine 50 mg/d qd

Capecitabine

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Capecitabine

Intervention Type DRUG

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

Perifosine Placebo

Intervention Type OTHER

Placebo to Perifosine 50 mg/d qd

Interventions

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Perifosine

Perifosine 50 mg/d qd

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Perifosine Placebo

Placebo to Perifosine 50 mg/d qd

Intervention Type OTHER

Other Intervention Names

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D-21266 KRX-0401 placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AEterna Zentaris

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig Henderson, MD

Role: STUDY_CHAIR

Online Collaborative Oncology Group

Locations

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AOI Pharmaceuticals Investigative Site

Tucson, Arizona, United States

Site Status

AOI Pharmaceuticals Investigative Site

Beverly Hills, California, United States

Site Status

AOI Pharmaceuticals Investigative Site

Deer Park, California, United States

Site Status

AOI Pharmaceuticals Investigative Site

Monterey, California, United States

Site Status

AOI Pharmaceuticals Investigative Site

Newport Beach, California, United States

Site Status

AOI Pharmaceuticals Investigative Site

Pomona, California, United States

Site Status

AOI Pharmaceuticals Investigative Site

Santa Rosa, California, United States

Site Status

AOI Pharmaceuticals Investigative Site

Soquel, California, United States

Site Status

AOI Pharmaceuticals Investigative Site

Stockton, California, United States

Site Status

AOI Pharmaceuticals Investigative Site

Colorado Springs, Colorado, United States

Site Status

AOI Pharmaceuticals Investigative Site

Greeley, Colorado, United States

Site Status

AOI Pharmaceuticals Investigative Site

Middletown, Connecticut, United States

Site Status

AOI Pharmaceuticals Investigative Site

Norwich, Connecticut, United States

Site Status

AOI Pharmaceuticals Investigative Site

Aventura, Florida, United States

Site Status

AOI Pharmaceuticals Investigative Site

Coral Springs, Florida, United States

Site Status

AOI Pharmaceuticals Investigative Site

Lake City, Florida, United States

Site Status

AOI Pharmaceuticals Investigative Site

Miami, Florida, United States

Site Status

AOI Pharmaceuticals Investigative Site

Ormond Beach, Florida, United States

Site Status

AOI Pharmaceuticals Investigative Site

Sebastian, Florida, United States

Site Status

AOI Pharmaceuticals Investigative Site

Vero Beach, Florida, United States

Site Status

AOI Pharmaceuticals Investigative Site

Augusta, Georgia, United States

Site Status

AOI Pharmaceuticals Investigative Site

Lawrenceville, Georgia, United States

Site Status

AOI Pharmaceuticals Investigative Site

Marietta, Georgia, United States

Site Status

AOI Pharmaceuticals Investigative Site

Galesburg, Illinois, United States

Site Status

AOI Pharmaceuticals Investigative Site

Park Ridge, Illinois, United States

Site Status

AOI Pharmaceuticals Investigative Site

Louisville, Kentucky, United States

Site Status

AOI Pharmaceuticals Investigative Site

Lafayette, Louisiana, United States

Site Status

AOI Pharmaceuticals Investigative Site

Grand Rapids, Michigan, United States

Site Status

AOI Pharmaceuticals Investigative Site

Kalamazoo, Michigan, United States

Site Status

AOI Pharmaceuticals Investigative Site

Branson, Missouri, United States

Site Status

AOI Pharmaceuticals Investigative Site

Billings, Montana, United States

Site Status

AOI Pharmaceuticals Investigative Site

Great Falls, Montana, United States

Site Status

AOI Pharmaceuticals Investigative Site

Albany, New York, United States

Site Status

AOI Pharmaceuticals Investigative Site

Armonk, New York, United States

Site Status

AOI Pharmaceuticals Investigative Site

Great Neck, New York, United States

Site Status

AOI Pharmaceuticals Investigative Site

Wilmington, North Carolina, United States

Site Status

AOI Pharmaceuticals Investigative Site

Dayton, Ohio, United States

Site Status

AOI Pharmaceuticals Investigative Site

Pottsville, Pennsylvania, United States

Site Status

AOI Pharmaceuticals Investigative Site

Sayre, Pennsylvania, United States

Site Status

AOI Pharmaceuticals Investigative Site

Greenville, South Carolina, United States

Site Status

AOI Pharmaceuticals Investigative Site

Chattanooga, Tennessee, United States

Site Status

AOI Pharmaceuticals Investigative Site

Memphis, Tennessee, United States

Site Status

AOI Pharmaceuticals Investigative Site

Dallas, Texas, United States

Site Status

AOI Pharmaceuticals Investigative Site

Dallas, Texas, United States

Site Status

AOI Pharmaceuticals Investigative Site

Tyler, Texas, United States

Site Status

AOI Pharmaceuticals Investigative Site

Chesapeake, Virginia, United States

Site Status

AOI Pharmaceuticals Investigative Site

Norfolk, Virginia, United States

Site Status

AOI Pharmaceuticals Investigative Site

Spokane, Washington, United States

Site Status

AOI Pharmaceuticals Investigative Site

Appleton, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21969495 (View on PubMed)

Other Identifiers

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Perifosine 211

Identifier Type: -

Identifier Source: org_study_id

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