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A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer


OBJECTIVES:

I. Determine the antitumor activity of perifosine in patients with recurrent or metastatic
squamous cell head and neck cancer.

II. Determine the time to progression and overall survival of patients treated with this
drug.

III. Determine the toxicity of this drug in these patients. IV. Determine the
pharmacodynamics of this drug in these patients. V. Assess the usefulness of biomarkers in
predicting response and other outcome parameters in patients treated with this drug.

VI. Assess the quality of life of patients treated with this drug.

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.

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Athanassios Argiris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02538

NCT ID:

NCT00062387

Start Date:

May 2003

Completion Date:

January 2007

Related Keywords:

  • Head and Neck Cancer
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent salivary gland cancer
  • salivary gland squamous cell carcinoma
  • stage IV salivary gland cancer
  • Head and Neck Neoplasms

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Ingalls Memorial Hospital Harvey, Illinois  60426
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Evanston Northwestern Health Care - Evanston Hospital Evanston, Illinois  60201
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Oncology Care Associates, P.L.L.C. Saint Joseph, Michigan  49085
LaGrange Memorial Hospital LaGrange, Illinois  60525