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NCT00398879 Clinical Trial

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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00398879
Other study ID # Perifosine 211
Secondary ID
Status Completed
Phase Phase 2
First received November 6, 2006
Last updated March 12, 2018
Start date August 2005
Est. completion date October 2011

Study information
Verified date February 2012
Source AEterna Zentaris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Perifosine
Perifosine 50 mg/d qd
• Capecitabine
Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks
Other:
• Perifosine Placebo
Placebo to Perifosine 50 mg/d qd

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
AEterna Zentaris

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome
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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