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

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI, Other CAN-NCIC-IND155 NCIC-155, NCT00053794, IND155

Objectives

1. 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.
2. Determine the toxicity of this drug in these patients.
3. 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

• 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

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/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.

Knowling 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		Ph: 613-544-2630

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