Perifosine in Treating Patients With Advanced Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
OBJECTIVES: 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.

Official Title
-----------------
A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: perifosine


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas not amenable to curative local therapy Metastatic OR locally advanced No known brain metastases No ascites that required therapeutic paracentesis on at least 2 occasions within the past 6 weeks PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN with liver metastases) Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Gastrointestinal No gastrointestinal (GI) tract disease resulting in the inability to take oral medication or a requirement for IV alimentation No uncontrolled inflammatory bowel disease No active peptic ulcer disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine No other active malignant disease that could interfere with interpretation of study results No ongoing active infection No other uncontrolled concurrent illness No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No more than 1 prior chemotherapy regimen for metastatic or locally advanced disease Prior chemotherapy, given as a radiosensitizer, allowed in addition to single-line therapy At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy likely to have myelotoxic effects (more than 3,000 cGy to fields including substantial marrow) and recovered Surgery No prior GI surgery affecting absorption Other No concurrent antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer agents or therapies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: perifosine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent pancreatic cancer, stage II pancreatic cancer, adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer