Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

May 6, 2003

Last Updated Date

July 23, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00059982 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

Official Title ^ICMJE

Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma

Brief Summary

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.

Detailed Description

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Pancreatic Cancer

Intervention ^ICMJE

Drug: perifosine

Study Arms / Comparison Groups

Publications *

Marsh Rde W, 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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

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

Hepatic

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

Renal

Creatinine no greater than 1.4 mg/dL

Cardiovascular

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

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

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

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy and recovered

Surgery

At least 4 weeks since prior surgery and recovered

Other

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00059982

Responsible Party

Study ID Numbers ^ICMJE

CDR0000298994, ECOG-E1202

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

August 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP