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Perifosine in Treating Patients With Advanced Pancreatic Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00053924
Collaborator
National Cancer Institute (NCI) (NIH)
3
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced or metastatic pancreatic cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the efficacy of perifosine, in terms of 6-month survival, in patients with advanced adenocarcinoma of the pancreas.

  • Determine the safety and tolerability of this drug in these patients.

  • Determine median survival time and the 1-year survival rate of patients treated with this drug.

  • Determine the objective response rate (partial and complete), response duration, and time to progression in patients treated with this drug.

  • Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive oral perifosine daily for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 15 months.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
Study Start Date :
May 1, 2003
Actual Primary Completion Date :
May 1, 2006

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 or cytologically confirmed adenocarcinoma of the pancreas not amenable to curative local therapy

    • Metastatic OR locally advanced

    • No known brain metastases

    • No ascites that required therapeutic paracentesis on at least 2 occasions within the past 6 weeks

    PATIENT CHARACTERISTICS:

    Age

    • 18 and over

    Performance status

    • ECOG 0-2 OR

    • Karnofsky 60-100%

    Life expectancy

    • Not specified

    Hematopoietic

    • WBC at least 3,000/mm^3

    • Absolute neutrophil count at least 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic

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

    • AST/ALT no greater than 2.5 times ULN (5 times ULN with liver metastases)

    Renal

    • Creatinine normal OR

    • Creatinine clearance at least 60 mL/min

    Cardiovascular

    • No symptomatic congestive heart failure

    • No unstable angina pectoris

    • No cardiac arrhythmia

    Gastrointestinal

    • No gastrointestinal (GI) tract disease resulting in the inability to take oral medication or a requirement for IV alimentation

    • No uncontrolled inflammatory bowel disease

    • No active peptic ulcer disease

    Other

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine

    • No other active malignant disease that could interfere with interpretation of study results

    • No ongoing active infection

    • No other uncontrolled concurrent illness

    • No psychiatric illness or social situation that would preclude study compliance

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • Not specified

    Chemotherapy

    • No more than 1 prior chemotherapy regimen for metastatic or locally advanced disease

    • Prior chemotherapy, given as a radiosensitizer, allowed in addition to single-line therapy

    • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

    Endocrine therapy

    • Not specified

    Radiotherapy

    • At least 3 weeks since prior radiotherapy likely to have myelotoxic effects (more than 3,000 cGy to fields including substantial marrow) and recovered

    Surgery

    • No prior GI surgery affecting absorption

    Other

    • No concurrent antiretroviral therapy for HIV-positive patients

    • No other concurrent investigational agents

    • No other concurrent anticancer agents or therapies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Margaret and Charles Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
    2 Cancer Care Ontario-London Regional Cancer Centre London Ontario Canada N6A 4L6
    3 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Malcolm J. Moore, MD, Princess Margaret Hospital, Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT00053924
    Other Study ID Numbers:
    • PMH-PHL-015
    • CDR0000269586
    • NCI-5983
    First Posted:
    Feb 6, 2003
    Last Update Posted:
    Jul 23, 2015
    Last Verified:
    Jul 1, 2015
    Keywords provided by University Health Network, Toronto
    recurrent pancreatic cancer
    stage II pancreatic cancer
    adenocarcinoma of the pancreas
    stage III pancreatic cancer
    stage IV pancreatic cancer
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Jul 23, 2015