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

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00059982
Collaborator
National Cancer Institute (NCI) (NIH)
10
Locations
25
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma
Study Start Date :
Jul 1, 2003
Actual Study Completion Date :
Aug 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    2 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
    3 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    4 Tufts - New England Medical Center Boston Massachusetts United States 02111
    5 CCOP - Duluth Duluth Minnesota United States 55805
    6 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    7 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    8 MBCCOP-Our Lady of Mercy Cancer Center Bronx New York United States 10466
    9 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    10 CCOP - Scott and White Hospital Temple Texas United States 76508

    Sponsors and Collaborators

    • Eastern Cooperative Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Robert de W. Marsh, MD, University of Florida
    • : Caio Max S. Rocha Lima, MD, H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00059982
    Other Study ID Numbers:
    • CDR0000298994
    • ECOG-E1202
    First Posted:
    May 7, 2003
    Last Update Posted:
    Jun 24, 2013
    Last Verified:
    Aug 1, 2004
    Keywords provided by , ,
    adenocarcinoma of the pancreas
    stage II pancreatic cancer
    stage III pancreatic cancer
    stage IV pancreatic cancer
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Jun 24, 2013