Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced, unresectable, or metastatic pancreatic cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma|
|Study Start Date:||July 2003|
|Study Completion Date:||August 2005|
- Determine the activity of perifosine, in terms of objective response, in patients with locally advanced, unresectable, or metastatic pancreatic cancer.
- Determine the response duration, progression-free survival, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral perifosine every 6 hours for a total of 6 doses and then once daily in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 35-84 patients will be accrued for this study within 21 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059982
|United States, Illinois|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Indiana|
|CCOP - Northern Indiana CR Consortium|
|South Bend, Indiana, United States, 46601|
|United States, Iowa|
|CCOP - Iowa Oncology Research Association|
|Des Moines, Iowa, United States, 50309-1016|
|United States, Massachusetts|
|Tufts - New England Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Minnesota|
|CCOP - Duluth|
|Duluth, Minnesota, United States, 55805|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, New York|
|MBCCOP-Our Lady of Mercy Cancer Center|
|Bronx, New York, United States, 10466|
|United States, North Dakota|
|CCOP - Merit Care Hospital|
|Fargo, North Dakota, United States, 58122|
|United States, Texas|
|CCOP - Scott and White Hospital|
|Temple, Texas, United States, 76508|
|Study Chair:||Robert de W. Marsh, MD||University of Florida|
|Investigator:||Caio Max S. Rocha Lima, MD||H. Lee Moffitt Cancer Center and Research Institute|