Clinical trial · Interventional
Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma
NCT00053794CI-TRIAL-00068558completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perifosine | Drug | Perifosine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 agentsReferences
Publications (1)
- RESULTKnowling M, Blackstein M, Tozer R, Bramwell V, Dancey J, Dore N, Matthews S, Eisenhauer E. A phase II study of perifosine (D-21226) in patients with previously untreated metastatic or locally advanced soft tissue sarcoma: A National Cancer Institute of Canada Clinical Trials Group trial. Invest New Drugs. 2006 Sep;24(5):435-9. doi: 10.1007/s10637-006-6406-7. PMID 16528479