Clinical trial · Interventional
Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase II Study Of Perifosine In Patients With Recurrent Or Metastatic Head And Neck Cancer
NCT00062387CI-TRIAL-00010527terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perifosine | Drug | Perifosine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: perifosine
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTArgiris A, Cohen E, Karrison T, Esparaz B, Mauer A, Ansari R, Wong S, Lu Y, Pins M, Dancey J, Vokes E. A phase II trial of perifosine, an oral alkylphospholipid, in recurrent or metastatic head and neck cancer. Cancer Biol Ther. 2006 Jul;5(7):766-70. doi: 10.4161/cbt.5.7.2874. Epub 2006 Jul 2. PMID 16760642