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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-NCIC-IND155 | Other Identifier | PDQ | |
| CDR0000269476 | Other Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perifosine | Drug |
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
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:
At least 1 unidimensionally measurable site of disease (outside the previously irradiated area) defined as:
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A. Eisenhauer, MD | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Center - Calgary | Calgary | Alberta | T2N 4N2 | Canada | ||
| British Columbia Cancer Agency - Vancouver Island Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16528479 | Result | Knowling 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. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D012509 | Sarcoma |
| D018234 | Sarcoma, Alveolar Soft Part |
| D006394 | Hemangiosarcoma |
| D005354 | Fibrosarcoma |
| D007890 | Leiomyosarcoma |
| D008080 | Liposarcoma |
| D013584 | Sarcoma, Synovial |
| D018203 | Sarcoma, Endometrial Stromal |
| C562740 | Hemangiopericytoma, Malignant |
| D051677 | Histiocytoma, Malignant Fibrous |
| D018319 | Neurofibrosarcoma |
| D012208 | Rhabdomyosarcoma |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C105905 | perifosine |
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| Vancouver |
| British Columbia |
| V5Z 4E6 |
| Canada |
| Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Mount Sinai Hospital - Toronto | Toronto | Ontario | M5G 1X5 | Canada |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009379 | Neoplasms, Muscle Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018205 | Neoplasms, Adipose Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D036821 | Endometrial Stromal Tumors |
| D051642 | Histiocytoma |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009217 | Myosarcoma |