Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma

NCT00064324 | Completed Phase 2

• 4 other identifiers: NCI-2012-02798MC02765972N01CM17104
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of perifosine in treating patients who have advanced soft tissue sarcoma. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.

Conditions

Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free rate

  6 months

Secondary Outcomes (5)

• Survival time

  Time from regstration to death due to any cause, assessed up to 5 years

• Time to disease progression

  Time from registration to documentation of disease progression, assessed up to 5 years

• Duration of response

  Date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 5 years

• Time to treatment failure

  Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years

• Average change over time for PK variable(s)

  Days 1 and 15 of course 1 and day 1 of courses 2-6

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: perifosine; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

perifosine DRUG

Given orally

Also known as: D21266, octadecylphosphopiperidine

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed advanced soft tissue sarcoma
• Measurable disease; measurable disease lesions that are being monitored for response and have been previously irradiated must have progressed \> 25% since completion of radiation therapy
• Absolute neutrophil count (ANC) \>= 1,500/uL
• PLT \>= 100,000/uL
• Total bilirubin =\< upper normal limit (UNL)
• AST =\< 2.5 x UNL
• Creatinine =\< UNL or calculated creatinine clearance \>= 60 mL/min (i.e. using the Cockcroft-Gault or Jeliffe methods)
• Life expectancy \>= 12 weeks
• ECOG performance status (PS) 0 or 1
• Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent

You may not qualify if:

• Any of the following as this regimen may be harmful to a developing fetus or nursing child:
• Pregnant women
• Breastfeeding women
• Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.)
• NOTE: Pregnant women are excluded from this study because perifosine is an alkylphospholipid with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with perifosine, breastfeeding should be discontinued if the mother is treated with perifosine
• Any of the following:
• \>= 3 prior cytotoxic chemotherapy regimens for metastatic sarcoma
• Chemotherapy =\< 4 weeks prior to study entry
• Nitrosoureas or mitomycin C =\< 6 weeks prior to study entry
• Radiotherapy =\< 4 weeks prior to study entry
• Immunotherapy =\< 4 weeks prior to study entry
• Biologic therapy =\< 4 weeks prior to study entry
• Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
• Uncontrolled brain metastases; NOTE: these patients are excluded because of the poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; however, if brain metastasis are treated and controlled for \> 8 weeks, the patient would be eligible for this study

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

perifosine; octadecyl-(N,N-dimethylpiperidino-4-yl)-phosphate

Condition Hierarchy (Ancestors)

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

Study Officials

• Howard Bailey

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: June 1, 2003
• Primary Completion: November 1, 2005
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)