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Phase II Study of Perifosine in Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Treatment
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Completed
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18 and over
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NCI, Other
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CAN-NCIC-IND155 NCIC-155, NCT00053794, IND155
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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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy 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 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
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
Expected Enrollment A total of 15-30 patients will be accrued for this study within 12-18 months. 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. Published ResultsKnowling M, Blackstein M, Tozer R, et al.: 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 24 (5): 435-9, 2006.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations NCIC-Clinical Trials Group | | | Elizabeth Eisenhauer, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma | | Trial Start Date | | 2003-05-30 | | Registered in ClinicalTrials.gov | | NCT00053794 | | Date Submitted to PDQ | | 2002-12-03 | | Information Last Verified | | 2004-05-26 | | NCI Grant/Contract Number | | CM17107 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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