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

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00053794

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

64.3

Actual Duration (Months)

2.8

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer Sarcoma	Drug: perifosine	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2003

Actual Primary Completion Date :

Sep 18, 2004

Actual Study Completion Date :

Sep 22, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
2	British Columbia Cancer Agency - Vancouver Island Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
3	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
4	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
5	Mount Sinai Hospital - Toronto	Toronto	Ontario	Canada	M5G 1X5
6	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	H1T 2M4