Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

NCIC-Clinical Trials Group

Elizabeth A. Eisenhauer

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00053794
Information obtained from ClinicalTrials.gov on December 14, 2011

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