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

Sarcoma Clinical Trial

Official title:

A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053794
• Other study ID #: I155
• Secondary ID: CAN-NCIC-IND155C
• Status: Completed
• Phase: Phase 2
• Start date: June 9, 2003
• Est. completion date: September 22, 2008

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 22, 2008
• Est. primary completion date: September 18, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Sarcoma

Intervention

Drug:
• perifosine

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Island Cancer Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

References & 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 Ca — View Citation