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A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma

Phase 2
18 Years
Not Enrolling
Endometrial Cancer, Sarcoma

Thank you

Trial Information

A Phase II Study Of Perifosine (D-21266) In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma


- Determine the efficacy of perifosine, in terms of response rate and duration of
response, in patients with untreated metastatic or locally advanced soft tissue

- 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

Inclusion Criteria


- 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

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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than upper limit of normal (ULN)

- AST no greater than 2.5 times ULN


- Creatinine no greater than ULN


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- 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

- No other concurrent uncontrolled illness


Biologic therapy

- Not specified


- 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


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive

- No concurrent radiotherapy to the sole site of measurable disease or for
progressively symptomatic disease


- At least 4 weeks since prior major surgery


- No other concurrent anticancer therapy or investigational agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Elizabeth A. Eisenhauer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Centre of Southeastern Ontario at Kingston General Hospital


United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

September 2008

Related Keywords:

  • Endometrial Cancer
  • Sarcoma
  • 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
  • Endometrial Neoplasms
  • Adenoma
  • Sarcoma