Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Sarcoma |
Drug: perifosine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma |
| Study Start Date: | May 2003 |
| Study Completion Date: | September 2008 |
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Alberta | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Vancouver Island Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Ontario | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Mount Sinai Hospital - Toronto | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Canada, Quebec | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Study Chair: | Elizabeth A. Eisenhauer, MD | Cancer Centre of Southeastern Ontario at Kingston General Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00053794 History of Changes |
| Other Study ID Numbers: | I155, CAN-NCIC-IND155, CDR0000269476 |
| Study First Received: | February 5, 2003 |
| Last Updated: | November 7, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by NCIC Clinical Trials Group:
|
adult alveolar soft-part sarcoma adult angiosarcoma adult fibrosarcoma adult leiomyosarcoma adult liposarcoma adult synovial sarcoma endometrial stromal sarcoma uterine leiomyosarcoma adult malignant hemangiopericytoma |
stage III adult soft tissue sarcoma stage III uterine sarcoma stage IV uterine sarcoma recurrent adult soft tissue sarcoma recurrent uterine sarcoma adult malignant fibrous histiocytoma adult neurofibrosarcoma adult rhabdomyosarcoma stage IV adult soft tissue sarcoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Adenoma Sarcoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue |
ClinicalTrials.gov processed this record on May 23, 2013