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



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 2005
End Date:October 2011

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A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients

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.

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.

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.
We found this trial at
48
sites
106 New Scotland Avenue
Albany, New York 12208
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Appleton, Wisconsin 54915
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Armonk, NY
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Augusta, GA
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Aventura, Florida 33180
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8314 Wilshire Boulevard
Beverly Hills, California 90211
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Beverly Hills, CA
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2376 Main Street
Billings, Montana 59101
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Branson, Missouri 65616
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Branson, MO
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Chattanooga, Tennessee 37404
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Chesapeake, Virginia 23320
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Colorado Springs, Colorado 80909
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3952 Coral Ridge Drive
Coral Springs, Florida 33065
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Dallas, TX
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Dayton, OH
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Deer Park, California 94574
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Galesburg, Illinois 61401
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Grand Rapids, Michigan 49546
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Great Falls, Montana 59405
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Great Neck, New York 11042
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Greeley, Colorado 80631
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1700 Perimeter Road
Greenville, South Carolina 29605
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Kalamazoo, Michigan 49048
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117 West Convent Street
Lafayette, Louisiana 70506
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Lake City, Florida 32055
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Lawrenceville, Georgia 30045
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Louisville, Kentucky 40202
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Marietta, Georgia 30060
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Memphis, Tennessee 38120
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Middletown, Connecticut 06457
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Monterey, California 93940
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Newport Beach, California 92663
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Norfolk, Virginia 23502
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Norwich, Connecticut 06360
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Ormond Beach, Florida 32174
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Park Ridge, Illinois 60068
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Pomona, California 91767
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Pottsville, Pennsylvania 17901
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Santa Rosa, California 95403
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Sayre, Pennsylvania 18840
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Sebastian, Florida 32958
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Soquel, California 95703
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Spokane, Washington 99218
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Stockton, California 95207
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Tucson, AZ
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433 South Vine Avenue
Tyler, Texas 75702
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Vero Beach, Florida 32960
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401 Chestnut Street
Wilmington, North Carolina 28401
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