Overview

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

Status:
Completed
Trial end date:
2008-09-22
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NCIC Clinical Trials Group
Collaborator:
National Cancer Institute (NCI)
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