Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00064324

Purpose

RATIONALE: Drugs used in chemotherapy such as perifosine 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 advanced soft tissue sarcoma.

Condition	Intervention	Phase
Sarcoma	Drug: perifosine	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Of Perifosine In Soft Tissue Sarcoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Perifosine

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Study Start Date:	June 2003
Study Completion Date:	January 2009
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the 6-month progression-free rate, time to progression, and survival of patients with advanced soft tissue sarcoma treated with perifosine.
Determine the objective tumor response status and duration of response in patients treated with this drug.
Determine the pharmacokinetics of this drug in these patients.
Determine the patterns of treatment failure and adverse event rate in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only. For all subsequent courses, patients receive oral perifosine once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 17-46 patients will be accrued for this study within 9-12 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed advanced soft tissue sarcoma
Measurable disease
- Lesions that have been previously irradiated must have progressed at least 25% since prior radiotherapy
No uncontrolled brain metastases
- Previously treated brain metastases are allowed provided they are controlled for more than 8 weeks prior to study entry

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

At least 12 weeks

Hematopoietic

Absolute neutrophil 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 OR
Creatinine clearance at least 60 mL/min

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No symptomatic cardiac arrhythmia despite appropriate therapy

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 concurrent uncontrolled illness
No ongoing or active infection
No psychiatric illness or social situations that would preclude study compliance
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 4 weeks since prior biologic therapy
More than 4 weeks since prior immunotherapy
No concurrent immunotherapy
No concurrent immunomodulating agents

Chemotherapy

No more than 2 prior cytotoxic chemotherapy regimens for metastatic sarcoma
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
No other concurrent chemotherapy

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
More than 4 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery

Not specified

Other

Recovered from prior therapy
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent commercial or other investigational agents or therapies for the malignancy
No other concurrent cytostatic or cytotoxic agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064324

Locations

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:

Howard H. Bailey, MD

University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Bailey HH, Mahoney MR, Ettinger DS, Maples WJ, Fracasso PM, Traynor AM, Erlichman C, Okuno SH. Phase II study of daily oral perifosine in patients with advanced soft tissue sarcoma. Cancer. 2006 Nov 15;107(10):2462-7.

Responsible Party:	Scott Okuno, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00064324 History of Changes
Other Study ID Numbers:	CDR0000315381, P30CA015083, MC0276, 5972
Study First Received:	July 8, 2003
Last Updated:	May 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

recurrent adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:

Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012