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

Launched by NCIC CLINICAL TRIALS GROUP · Feb 5, 2003

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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