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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059982
• Other study ID #: CDR0000298994
• Secondary ID: ECOG-E1202
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2003
• Last updated: June 21, 2013
• Start date: July 2003
• Est. completion date: August 2005

Study information

• Verified date: August 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• perifosine

Locations

Country	Name	City	State
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	MBCCOP-Our Lady of Mercy Cancer Center	Bronx	New York
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Carle Cancer Center	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation