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Sarcoma Alliance for Research Through Collaboration (SARC) Multicenter Trial: A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas

Phase 2
13 Years
Not Enrolling
Chondrosarcomas, Alveolar Soft Part Sarcomas, Extra Skeletal Myxoid Chondrosarcomas

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Trial Information

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.

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.


- 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

- 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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Dejka Araujo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

MD Anderson Cancer Center, Dept of Sarcoma


United States: Food and Drug Administration

Study ID:

Perifosine 214



Start Date:

November 2006

Completion Date:

October 2011

Related Keywords:

  • Chondrosarcomas
  • Alveolar Soft Part Sarcomas
  • Extra Skeletal Myxoid Chondrosarcomas
  • Chemo Insensitive Sarcomas
  • Chondrosarcomas
  • Alveolar soft part sarcomas
  • Extra skeletal myxoid chondrosarcomas
  • Perifosine
  • Chondrosarcoma
  • Sarcoma, Alveolar Soft Part
  • Sarcoma