Perifosine In Treating Patients With Locally Advanced, Unresectable, Or Metastatic Pancreatic Cancer

Study Overview

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.

OBJECTIVES: * 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.

Pancreatic Cancer

DRUG: perifosine

CDR0000298994
ECOG-E1202

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 2003-05-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-21
First Submitted that Met QC Criteria 2003-05-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-24
First Posted (ESTIMATED) 2003-05-07	Results First Posted N/A	Last Verified 2004-08

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 confirmed adenocarcinoma of the pancreas
Locally advanced, unresectable, or metastatic disease
Measurable disease
No known brain metastases

18 and over

ECOG 0-1

Not specified

WBC at least 3,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL

AST no greater than 2 times upper limit of normal (ULN)
Bilirubin no greater than 2 times ULN

Creatinine no greater than 1.4 mg/dL

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

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No other concurrent illness that would preclude study participation

Not specified

No prior chemotherapy for pancreatic cancer
More than 6 months since prior chemotherapy for other diseases

Not specified

At least 4 weeks since prior radiotherapy and recovered

At least 4 weeks since prior surgery and recovered

No other concurrent investigational agents for pancreatic cancer
No concurrent combination antiretroviral therapy for HIV-positive patients

Collaborators and Investigators

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

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Robert de W. Marsh, MD, University of Florida

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

Marsh Rde W, Rocha Lima CM, Levy DE, Mitchell EP, Rowland KM Jr, Benson AB 3rd. A phase II trial of perifosine in locally advanced, unresectable, or metastatic pancreatic adenocarcinoma. Am J Clin Oncol. 2007 Feb;30(1):26-31. doi: 10.1097/01.coc.0000251235.46149.43.

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Clinical Trial Record