Colon Cancer Clinical Trial
Official title:
A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients
Verified date | February 2012 |
Source | AEterna Zentaris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 381 |
Est. completion date | October 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | AOI Pharmaceuticals Investigative Site | Albany | New York |
United States | AOI Pharmaceuticals Investigative Site | Appleton | Wisconsin |
United States | AOI Pharmaceuticals Investigative Site | Armonk | New York |
United States | AOI Pharmaceuticals Investigative Site | Augusta | Georgia |
United States | AOI Pharmaceuticals Investigative Site | Aventura | Florida |
United States | AOI Pharmaceuticals Investigative Site | Beverly Hills | California |
United States | AOI Pharmaceuticals Investigative Site | Billings | Montana |
United States | AOI Pharmaceuticals Investigative Site | Branson | Missouri |
United States | AOI Pharmaceuticals Investigative Site | Chattanooga | Tennessee |
United States | AOI Pharmaceuticals Investigative Site | Chesapeake | Virginia |
United States | AOI Pharmaceuticals Investigative Site | Colorado Springs | Colorado |
United States | AOI Pharmaceuticals Investigative Site | Coral Springs | Florida |
United States | AOI Pharmaceuticals Investigative Site | Dallas | Texas |
United States | AOI Pharmaceuticals Investigative Site | Dallas | Texas |
United States | AOI Pharmaceuticals Investigative Site | Dayton | Ohio |
United States | AOI Pharmaceuticals Investigative Site | Deer Park | California |
United States | AOI Pharmaceuticals Investigative Site | Galesburg | Illinois |
United States | AOI Pharmaceuticals Investigative Site | Grand Rapids | Michigan |
United States | AOI Pharmaceuticals Investigative Site | Great Falls | Montana |
United States | AOI Pharmaceuticals Investigative Site | Great Neck | New York |
United States | AOI Pharmaceuticals Investigative Site | Greeley | Colorado |
United States | AOI Pharmaceuticals Investigative Site | Greenville | South Carolina |
United States | AOI Pharmaceuticals Investigative Site | Kalamazoo | Michigan |
United States | AOI Pharmaceuticals Investigative Site | Lafayette | Louisiana |
United States | AOI Pharmaceuticals Investigative Site | Lake City | Florida |
United States | AOI Pharmaceuticals Investigative Site | Lawrenceville | Georgia |
United States | AOI Pharmaceuticals Investigative Site | Louisville | Kentucky |
United States | AOI Pharmaceuticals Investigative Site | Marietta | Georgia |
United States | AOI Pharmaceuticals Investigative Site | Memphis | Tennessee |
United States | AOI Pharmaceuticals Investigative Site | Miami | Florida |
United States | AOI Pharmaceuticals Investigative Site | Middletown | Connecticut |
United States | AOI Pharmaceuticals Investigative Site | Monterey | California |
United States | AOI Pharmaceuticals Investigative Site | Newport Beach | California |
United States | AOI Pharmaceuticals Investigative Site | Norfolk | Virginia |
United States | AOI Pharmaceuticals Investigative Site | Norwich | Connecticut |
United States | AOI Pharmaceuticals Investigative Site | Ormond Beach | Florida |
United States | AOI Pharmaceuticals Investigative Site | Park Ridge | Illinois |
United States | AOI Pharmaceuticals Investigative Site | Pomona | California |
United States | AOI Pharmaceuticals Investigative Site | Pottsville | Pennsylvania |
United States | AOI Pharmaceuticals Investigative Site | Santa Rosa | California |
United States | AOI Pharmaceuticals Investigative Site | Sayre | Pennsylvania |
United States | AOI Pharmaceuticals Investigative Site | Sebastian | Florida |
United States | AOI Pharmaceuticals Investigative Site | Soquel | California |
United States | AOI Pharmaceuticals Investigative Site | Spokane | Washington |
United States | AOI Pharmaceuticals Investigative Site | Stockton | California |
United States | AOI Pharmaceuticals Investigative Site | Tucson | Arizona |
United States | AOI Pharmaceuticals Investigative Site | Tyler | Texas |
United States | AOI Pharmaceuticals Investigative Site | Vero Beach | Florida |
United States | AOI Pharmaceuticals Investigative Site | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
AEterna Zentaris |
United States,
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 colore — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effects of perifosine on time to progression | Time to progression will be measured from the first day of study drug until progression. | Every 12 weeks | |
Secondary | Toxicity | Determination of the toxicity of single agent chemotherapy in combination with perifosine. Toxicity evaluation is to be performed throughout the study. | Every 12 weeks | |
Secondary | Comparison of time to progression to historical experience | To compare the time to progression of chemotherapy in combination with placebo to historical experience. | Every 12 weeks |
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