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Perifosine in Treating Patients With Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
perifosine
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Sites / Locations

  • Margaret and Charles Juravinski Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
July 22, 2015
Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053924
Brief Title
Perifosine in Treating Patients With Advanced Pancreatic Cancer
Official Title
A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, stage II pancreatic cancer, adenocarcinoma of the pancreas, 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm J. Moore, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Perifosine in Treating Patients With Advanced Pancreatic Cancer

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