Perifosine in Treating Patients With Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced or metastatic pancreatic cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma|
|Study Start Date:||May 2003|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
- Determine the efficacy of perifosine, in terms of 6-month survival, in patients with advanced adenocarcinoma of the pancreas.
- Determine the safety and tolerability of this drug in these patients.
- Determine median survival time and the 1-year survival rate of patients treated with this drug.
- Determine the objective response rate (partial and complete), response duration, and time to progression in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive oral perifosine daily for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 15 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053924
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Malcolm J. Moore, MD||Princess Margaret Hospital, Canada|