A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

This study has been completed.
Sponsor:
Collaborator:
Sarcoma Alliance for Research through Collaboration
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT00401388
First received: November 17, 2006
Last updated: March 4, 2013
Last verified: February 2012

November 17, 2006
March 4, 2013
November 2006
January 2011   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Response Rate
Complete list of historical versions of study NCT00401388 on ClinicalTrials.gov Archive Site
  • Time to progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stable disease of six months or greater [ Time Frame: >= 6 months ] [ Designated as safety issue: No ]
  • Time to progression
  • Stable disease of six months or greater
Not Provided
Not Provided
 
A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas
Sarcoma Alliance for Research Through Collaboration (SARC) Multicenter Trial: A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression. The goals of this study include:

  • In this study a daily dose of perifosine previously determined to be relatively non-toxic will be evaluated in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas.
  • Response to therapy will be based on regression of measurable disease according to Choi criteria. Time to progression and duration of stable disease will be measured as secondary endpoints of the study.

This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression.

Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food. Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients. Patients may need anti-emetics and/or anti-diarrheals. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced. Evaluation of all lesions for progression or response will be made at 3-month intervals.

STUDY KEY POINTS

  • Treatment will be administered on an outpatient basis in 28-day cycles.
  • Growth factors should not be needed, however, use by patients on this trial is NOT prohibited.
  • A favorable outcome will be defined as a complete or partial response according to the Choi criteria or stable disease by the Choi criteria for 6 months or longer.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chondrosarcomas
  • Alveolar Soft Part Sarcomas
  • Extra Skeletal Myxoid Chondrosarcomas
  • Drug: Perifosine
    Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
    Other Name: perifosine
  • Drug: Perifosine
    Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
    Other Name: perifosine
  • Experimental: chondrosarcoma
    Patients with confirmed chondrosarcoma.
    Interventions:
    • Drug: Perifosine
    • Drug: Perifosine
  • Experimental: myxoid chondrosarcoma
    Patients with confirmed extra-skeletal myxoid chondrosarcoma.
    Interventions:
    • Drug: Perifosine
    • Drug: Perifosine
  • Experimental: alveolar soft part sarcoma
    Patients with confirmed alveolar soft part sarcoma.
    Interventions:
    • Drug: Perifosine
    • Drug: Perifosine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed diagnosis of chondrosarcoma, extra-skeletal myxoid chondrosarcoma or alveolar soft part sarcoma.
  • Patients may have had prior chemotherapy, but if the patient has had three or more forms of prior chemotherapy for metastases, the patient's clinical course should be discussed with the study chairman before the patient is enrolled on study
  • Patients must have progression of disease by Choi criteria.
  • ECOG performance status 0-1. Patients with ECOG PS of 2 may be admitted with approval from the study chairman.
  • At least 13 years of age.
  • Patients must have measurable disease.
  • Patients who have brain metastases that have not progressed for at least 2 months following surgery or radiotherapy will be considered after discussion with the study chairman.
  • Patients must have a life expectancy of more than 3 months.
  • Patients must have normal organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor, and the study chairman agree the abnormality is unlikely to affect the safety of perifosine use. Normal organ and marrow function is described below:

    • ANC >1.5 x 109 /L
    • Platelets >75,000/ mm3
    • HCT > 28% (with or without growth factor support)
    • Creatinine <= 2.5 mg/dl
    • Total bilirubin < 1.5 x upper limit of normal
    • Transaminase <= 2.5 x upper limit of normal
  • Patients must have recovered from acute toxicity related to prior therapy, including surgery or radiotherapy to grade <= 1 (excluding alopecia) at the time of enrollment.
  • Patients must be able to ingest oral medications or to obtain them through a gastrostomy tube.
  • Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception to prevent pregnancy while on therapy and for four weeks after the completion of treatment.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients receiving investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy, except bisphosphonates.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  • Uncontrolled intercurrent illness—including, but not limited to, ongoing or active infection—and psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00401388
Perifosine 214
Yes
AEterna Zentaris
AEterna Zentaris
Sarcoma Alliance for Research through Collaboration
Study Chair: Dejka Araujo, MD MD Anderson Cancer Center, Dept of Sarcoma
AEterna Zentaris
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP