Perifosine In Treating Patients With Advanced Pancreatic Cancer

Study Overview

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.

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.

Pancreatic Cancer

DRUG: perifosine

PMH-PHL-015
CDR0000269586 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))
NCI-5983

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2003-02-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-07-22
First Submitted that Met QC Criteria 2003-02-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-07-23
First Posted (ESTIMATED) 2003-02-06	Results First Posted N/A	Last Verified 2015-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

ECOG 0-2 OR
Karnofsky 60-100%

Not specified

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

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)

Creatinine normal OR
Creatinine clearance at least 60 mL/min

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

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

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

Not specified

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

Not specified

At least 3 weeks since prior radiotherapy likely to have myelotoxic effects (more than 3,000 cGy to fields including substantial marrow) and recovered

No prior GI surgery affecting absorption

No concurrent antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer agents or therapies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Malcolm J. Moore, MD, Princess Margaret Hospital, Canada

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record