NCT00053794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
4 months until next milestone

Study Start

First participant enrolled

June 9, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2004

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2008

Completed
Last Updated

August 4, 2023

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

February 5, 2003

Last Update Submit

August 3, 2023

Conditions

Endometrial CancerSarcoma

Keywords

adult alveolar soft-part sarcomaadult angiosarcomaadult fibrosarcomaadult leiomyosarcomaadult liposarcomaadult synovial sarcomaendometrial stromal sarcomauterine leiomyosarcomaadult malignant hemangiopericytomastage III adult soft tissue sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent adult soft tissue sarcomarecurrent uterine sarcomaadult malignant fibrous histiocytomaadult neurofibrosarcomaadult rhabdomyosarcomastage IV adult soft tissue sarcoma

Interventions

perifosineDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

British Columbia Cancer Agency - Vancouver Island Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 16528479RESULT

MeSH Terms

Conditions

Endometrial NeoplasmsSarcomaSarcoma, Alveolar Soft PartHemangiosarcomaFibrosarcomaLeiomyosarcomaLiposarcomaSarcoma, SynovialSarcoma, Endometrial StromalHemangiopericytoma, MalignantHistiocytoma, Malignant FibrousNeurofibrosarcomaRhabdomyosarcoma

Interventions

perifosine

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Muscle TissueNeoplasms, Vascular TissueNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Adipose TissueNeoplasms, Complex and MixedEndometrial Stromal TumorsHistiocytomaNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissuePeripheral Nervous System NeoplasmsNervous System NeoplasmsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesMyosarcoma

Study Officials

  • Elizabeth A. Eisenhauer, MD

    Cancer Centre of Southeastern Ontario at Kingston General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

June 9, 2003

Primary Completion

September 18, 2004

Study Completion

September 22, 2008

Last Updated

August 4, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)