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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sarcoma, Endometrial Cancer

Intervention / Treatment
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* Drug: perifosine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: perifosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult alveolar soft-part sarcoma, adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult synovial sarcoma, endometrial stromal sarcoma, uterine leiomyosarcoma, adult malignant hemangiopericytoma, stage III adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent adult soft tissue sarcoma, recurrent uterine sarcoma, adult malignant fibrous histiocytoma, adult neurofibrosarcoma, adult rhabdomyosarcoma, stage IV adult soft tissue sarcoma