Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients
|ClinicalTrials.gov Identifier: NCT00398879|
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : March 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: Perifosine Drug: Capecitabine Other: Perifosine Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||381 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||October 2011|
Experimental: Arm 1: Perifosine + Capecitabine
Perifosine 50 mg/d qd + Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks until progression
Perifosine 50 mg/d qd
Other Names:Drug: Capecitabine
Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeks
Placebo Comparator: 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
Capecitabine 825 mg/m^2 BID days 1 - 14 q 3 weeksOther: Perifosine Placebo
Placebo to Perifosine 50 mg/d qd
Other Name: placebo
- Effects of perifosine on time to progression [ Time Frame: Every 12 weeks ]Time to progression will be measured from the first day of study drug until progression.
- Toxicity [ Time Frame: Every 12 weeks ]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 [ Time Frame: Every 12 weeks ]To compare the time to progression of chemotherapy in combination with placebo to historical experience.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398879
Show 49 Study Locations
|Study Chair:||Craig Henderson, MD||Online Collaborative Oncology Group|