Phase I Perifosine and Gemcitabine Study
This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs before this study. The study is designed to determine the highest dose of perifosine that can be administered to people every day while they are on a Gemcitabine regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is found, we will add 10 more patients at that dose.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Trial of the Combination of Perifosine and Gemcitabine|
- GI Toxicities
- Other toxicities
- Disease progression
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||January 2006|
This is a phase 1, open-label trial of perifosine and gemcitabine in patients with malignancies for whom single agent gemcitabine is a reasonable treatment option. All patients will receive gemcitabine at a dose of 1000 mg/m2 on days 1 and 8 of a 21-day cycle. Patients will receive perifosine orally at a dose of 50, 100 or 150 mg per day for the first 14 days of the 21-day cycle. Cohorts of 3 patients will be treated with doses of 50 mg administered either once, twice or three times a day. In this study a maximum tolerated dose (MTD) will be defined as a dose that can be given without grade 3/4 non-hematologic toxicity in more than 1/3 patients. If 2/3 patients in any cohort encounter a grade 3/4 non-hematologic toxicity, an additional 3 patients will be added. If the dose is intolerable for >3/6 patients then the previous level will be declared the MTD. Once an MTD has been determined an additional 10 patients will be added at the MTD to better define the expected toxicities.