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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
perifosine
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Carle Cancer Center
  • CCOP - Northern Indiana CR Consortium
  • CCOP - Iowa Oncology Research Association
  • Tufts - New England Medical Center
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • MBCCOP-Our Lady of Mercy Cancer Center
  • CCOP - Merit Care Hospital
  • CCOP - Scott and White Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
June 21, 2013
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00059982
Brief Title
Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Official Title
Phase II Trial Of Perifosine In Locally Advanced, Unresectable Or Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
perifosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert de W. Marsh, MD
Organizational Affiliation
University of Florida
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Caio Max S. Rocha Lima, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Facility Information:
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
MBCCOP-Our Lady of Mercy Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17278891
Citation
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. doi: 10.1097/01.coc.0000251235.46149.43.
Results Reference
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Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

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