A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
The primary purpose of Part I of this study was to determine the maximum dose of perifosine
that can be administered with tolerable gastrointestinal toxicity; and to obtain preliminary
information on the response rate of perifosine in non-small cell lung cancer. In addition,
the trial was and is designed to provide some insight into the nature of the anti-tumor
effect, the time to response, and dose-schedules that should be used in future trials.
Part 2 - In the second part of this study, patients will be randomized to one of 3
dose-schedules of perifosine and to test if the response rate of perifosine in non small
cell lung cancer is > 10% in any of the 3 arms of the study. The study is not designed to
compare the response rates in the 3 arms of the trial, but toxicities will be compared.
The regimens are:
- A weekly dose of 900 mg to be divided into three doses of 300 mg each. If patients
experience no grade 2 toxicities during their first month of therapy, the dose will be
escalated to 1,200 mg divided into four doses of 300 mg.
- A daily dose of 150 mg to be divided into three doses of 50 mg each. If patients
experience no grade 2 toxicities during their first month of therapy, the dose will be
escalated to 200 mg divided into four doses of 50 mg.
- A daily dose of 150 mg to be given in one dose at bedtime. If patients experience no
grade 2 toxicities during their first month of therapy, the dose will be escalated to
200 mg to be given in one dose at bedtime.
Patients receiving weekly perifosine will receive prophylactic antiemetics. Patients
receiving daily perifosine will not routinely receive prophylactic antiemetics unless they
experience nausea. All patients may continue therapy unless disease progression is
documented on two occasions at least 4 weeks apart. Patients who experience toxicity may
continue on treatment with doses delayed or reduced.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Gastrointestinal toxicity of 3 different dose-schedules
4 weeks
Yes
David Spigel, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Food and Drug Administration
Perifosine 201
NCT00399789
September 2004
December 2011
Name | Location |
---|---|
AOI Pharmaceuticals Investigative Site | Berkeley, California 94704 |
AOI Pharmaceuticals Investigative Site | Atlanta, Georgia 30322 |
AOI Pharmaceuticals Investigative Site | Chicago, Illinois 60611 |
AOI Pharmaceuticals Investigative Site | Ann Arbor, Michigan 48103 |
AOI Pharmaceuticals Investigative Site | Orlando, Florida 32804 |
AOI Pharmaceuticals Investigative Site | Greenville, South Carolina 29605 |
AOI Pharmaceuticals Investigative Site | Dallas, Texas 75246 |
AOI Pharmaceuticals Investigative Site | Tuscon, Arizona 85704 |
AOI Pharmaceuticals Investigative Site | Billings, Montana 59103 |
AOI Pharmaceuticals Investigative Site | Albany, New York 12208 |
AOI Pharmaceuticals Investigative Site | Chattanooga, Tennessee 37404 |
AOI Pharmaceuticals Investigative Site | New Albany, Indiana 47150 |
AOI Pharmaceuticals Investigative Site | Albuquerque, New Mexico 87109 |