Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: perifosine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer |
| Enrollment: | 46 |
| Study Start Date: | May 2003 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: perifosine |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| LaGrange Memorial Hospital | |
| LaGrange, Illinois, United States, 60525 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61602 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Michigan | |
| Oncology Care Associates, P.L.L.C. | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Chair: | Athanassios Argiris, MD | Robert H. Lurie Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062387 History of Changes |
| Other Study ID Numbers: | NCI-2012-02538, UCCRC-12198A, NCI-5938, CDR0000304740 |
| Study First Received: | June 5, 2003 |
| Last Updated: | May 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013