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

• Status: Terminated
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent or metastatic head and neck cancer. Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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

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/mm^3

• Absolute neutrophil count at least 1,500/mm^3

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

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

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)

Radiotherapy

• At least 4 weeks since prior radiotherapy

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