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