Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00053794
First received: February 5, 2003
Last updated: November 7, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Study Start Date: May 2003
Study Completion Date: September 2008
Detailed Description:

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053794

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
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
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:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on October 23, 2014