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

NCT ID: NCT00053794

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-09
• Study Completion Date: 2008-09-22

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.

Conditions

Endometrial Cancer; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

perifosine

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth A. Eisenhauer, MD

Role: STUDY_CHAIR

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Locations

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

British Columbia Cancer Agency - Vancouver Island Cancer Centre

Vancouver, British Columbia, Canada

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Mount Sinai Hospital - Toronto

Toronto, Ontario, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 16528479 (View on PubMed)

Other Identifiers

CAN-NCIC-IND155

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000269476

Identifier Type: OTHER

Identifier Source: secondary_id

I155

Identifier Type: -

Identifier Source: org_study_id