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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00059982
First received: May 6, 2003
Last updated: June 21, 2013
Last verified: August 2004

May 6, 2003
June 21, 2013
July 2003
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Complete list of historical versions of study NCT00059982 on ClinicalTrials.gov Archive Site
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Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
Drug: perifosine
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2005
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00059982
CDR0000298994, ECOG-E1202
Not Provided
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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
National Cancer Institute (NCI)
August 2004

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