Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	UCCRC-12198A NCI-5938, 5938, NCT00062387

Objectives

1. Determine the antitumor activity of perifosine in patients with recurrent or metastatic squamous cell head and neck cancer.
2. Determine the time to progression and overall survival of patients treated with this drug.
3. Determine the toxicity of this drug in these patients.
4. Determine the pharmacodynamics of this drug in these patients.
5. Assess the usefulness of biomarkers in predicting response and other outcome parameters in patients treated with this drug.
6. Assess the quality of life of patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed squamous cell cancer of the head and neck
  • Metastatic or recurrent disease
  • Not amenable to surgery or radiotherapy



• Unidimensionally measurable disease
  • At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by CT scan



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No more than 1 prior biologic/targeted regimen for recurrent or metastatic disease

Chemotherapy

• No more than 1 prior adjuvant or neoadjuvant chemotherapy and/or concurrent chemoradiotherapy regimen
• No more than 1 prior chemotherapy regimen for recurrent or metastatic disease
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• Recovered from prior therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin normal
• AST/ALT no greater than 2.5 times upper limit of normal

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to perifosine
• No ongoing or active infection
• No other concurrent uncontrolled illness
• No psychiatric illness or social situation that would limit compliance with study requirements

Expected Enrollment

A total of 22-46 patients will be accrued for this study within 2 years.

Outline

This is a multicenter study.

Patients receive oral perifosine 4 times daily on days 1 and 2 and once daily on days 3-28 during course 1. Patients receive oral perifosine once daily on days 1-28 for all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weekly during the first month, every 28 days after the first month, and then at study withdrawal.

Patients are followed every 3 months.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Athanassios Argiris, MD, Protocol chair(Contact information may not be current)		Ph: 312-695-4441

Registry Information
Official Title		A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer
Trial Start Date		2003-05-09
Trial Completion Date		2007-01-16
Registered in ClinicalTrials.gov		NCT00062387
Date Submitted to PDQ		2003-05-06
Information Last Verified		2004-10-12
NCI Grant/Contract Number		P30-CA14599, N01-CA17102

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