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Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma

Primary Purpose

Endometrial Cancer, Sarcoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
perifosine
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring adult alveolar soft-part sarcoma, adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult synovial sarcoma, endometrial stromal sarcoma, uterine leiomyosarcoma, adult malignant hemangiopericytoma, stage III adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent adult soft tissue sarcoma, recurrent uterine sarcoma, adult malignant fibrous histiocytoma, adult neurofibrosarcoma, adult rhabdomyosarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or locally advanced soft tissue sarcoma that is incurable by standard therapies, including any of the following types: Uterine sarcomas Mixed mesodermal Leiomyosarcoma Endometrial stromal sarcoma Alveolar soft part sarcoma Angiosarcoma/lymphangiosarcoma Fibrosarcoma Hemangiopericytoma Leiomyosarcoma Liposarcoma Malignant fibrous histiocytoma Neurogenic sarcoma Pleomorphic rhabdomyosarcoma Synovial sarcoma Unclassifiable sarcoma Undifferentiated sarcoma Excluded diseases include the following: Bone sarcomas (e.g., osteosarcoma, Ewing's sarcoma, chondrosarcoma) Embryonal rhabdomyosarcoma Carcinosarcoma Kaposi's sarcoma Malignant mesothelioma Neuroblastoma Gastrointestinal stromal tumor At least 1 unidimensionally measurable site of disease (outside the previously irradiated area) defined as: At least 20 mm by x-ray or physical exam At least 10 mm by spiral CT scan At least 20 mm by non-spiral CT scan NOTE: Bone lesions are not considered measurable NOTE: Patients whose sole site of disease is within a previously irradiated area are allowed if there is evidence of progression or new lesions in the irradiated field No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal Creatinine no greater than ULN 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 prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix No active or ongoing infection No psychiatric illness or social situation that would limit compliance with study requirements No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior systemic chemotherapy for metastatic or locally advanced disease At least 6 months since prior adjuvant chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) No concurrent radiotherapy to the sole site of measurable disease or for progressively symptomatic disease Surgery At least 4 weeks since prior major surgery Other No other concurrent anticancer therapy or investigational agents

Sites / Locations

  • Tom Baker Cancer Center - Calgary
  • British Columbia Cancer Agency - Vancouver Island Cancer Centre
  • Margaret and Charles Juravinski Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Mount Sinai Hospital - Toronto
  • Maisonneuve-Rosemont Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053794
Brief Title
Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
Official Title
A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 9, 2003 (Actual)
Primary Completion Date
September 18, 2004 (Actual)
Study Completion Date
September 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

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 metastatic or locally advanced soft tissue sarcoma.
Detailed Description
OBJECTIVES: Determine the efficacy of perifosine, in terms of response rate and duration of response, in patients with untreated metastatic or locally advanced soft tissue sarcoma. Determine the toxicity of this drug in these patients. Determine the early progression rate in patients treated with this drug. OUTLINE: This is a non-randomized, non-blinded, multicenter study. Patients receive a loading dose of oral perifosine twice on day 1 and then once daily on days 2-21 for the first course. For all subsequent courses, patients receive a loading dose of oral perifosine once on day 1 and then once daily on days 2-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 1 month. Patients with stable or responsive disease are followed every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Sarcoma
Keywords
adult alveolar soft-part sarcoma, adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult synovial sarcoma, endometrial stromal sarcoma, uterine leiomyosarcoma, adult malignant hemangiopericytoma, stage III adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent adult soft tissue sarcoma, recurrent uterine sarcoma, adult malignant fibrous histiocytoma, adult neurofibrosarcoma, adult rhabdomyosarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
perifosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or locally advanced soft tissue sarcoma that is incurable by standard therapies, including any of the following types: Uterine sarcomas Mixed mesodermal Leiomyosarcoma Endometrial stromal sarcoma Alveolar soft part sarcoma Angiosarcoma/lymphangiosarcoma Fibrosarcoma Hemangiopericytoma Leiomyosarcoma Liposarcoma Malignant fibrous histiocytoma Neurogenic sarcoma Pleomorphic rhabdomyosarcoma Synovial sarcoma Unclassifiable sarcoma Undifferentiated sarcoma Excluded diseases include the following: Bone sarcomas (e.g., osteosarcoma, Ewing's sarcoma, chondrosarcoma) Embryonal rhabdomyosarcoma Carcinosarcoma Kaposi's sarcoma Malignant mesothelioma Neuroblastoma Gastrointestinal stromal tumor At least 1 unidimensionally measurable site of disease (outside the previously irradiated area) defined as: At least 20 mm by x-ray or physical exam At least 10 mm by spiral CT scan At least 20 mm by non-spiral CT scan NOTE: Bone lesions are not considered measurable NOTE: Patients whose sole site of disease is within a previously irradiated area are allowed if there is evidence of progression or new lesions in the irradiated field No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal Creatinine no greater than ULN 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 prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix No active or ongoing infection No psychiatric illness or social situation that would limit compliance with study requirements No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior systemic chemotherapy for metastatic or locally advanced disease At least 6 months since prior adjuvant chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) No concurrent radiotherapy to the sole site of measurable disease or for progressively symptomatic disease Surgery At least 4 weeks since prior major surgery Other No other concurrent anticancer therapy or investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Eisenhauer, MD
Organizational Affiliation
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Island Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
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
Mount Sinai Hospital - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16528479
Citation
Knowling M, Blackstein M, Tozer R, Bramwell V, Dancey J, Dore N, Matthews S, Eisenhauer E. A phase II study of perifosine (D-21226) in patients with previously untreated metastatic or locally advanced soft tissue sarcoma: A National Cancer Institute of Canada Clinical Trials Group trial. Invest New Drugs. 2006 Sep;24(5):435-9. doi: 10.1007/s10637-006-6406-7.
Results Reference
result

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Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma

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