|Phase II||Supportive care, Treatment||Completed||18 and over||NCI, Other||CCCWFU97509|
U10CA081851, WFU-08-03-06, CEPHALON-CCCWFU-97509, NCT01032200
RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain.
PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.
Further Study Information
- To estimate study accrual, adherence, retention, and participation of patients with primary brain tumors undergoing partial- or whole-brain radiotherapy who are randomized to receive armodafinil or placebo.
- To estimate the variability of fatigue, quality of life, and neurocognitive function in these patients.
- To obtain a preliminary estimate of the effect of armodafinil on fatigue as measured by the fatigue subscale of the FACIT-F and the Brief Fatigue Inventory.
- To estimate the rates of toxicity and adverse events associated with armodafinil.
- To obtain preliminary estimates of the effect of armodafinil on sleepiness as measured by the Epworth Sleep Scale; overall quality of life and brain-specific quality of life as measured by the FACT-G with the brain subscale; and cognitive function as measured by a comprehensive Wake Forest Cognitive Function Battery.
OUTLINE: This is a multicenter study. Patients are stratified according to therapy (radiotherapy alone vs radiotherapy and chemotherapy) and Karnofsky performance status (60-80% vs 90-100%). Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Patients complete questionnaires assessing fatigue, quality of life, and neurocognitive function at baseline and periodically during study.
- Histologically confirmed primary brain tumor, including any of the following:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Low-grade glioma
- Other primary brain tumor histologies
- Planning to undergo external-beam cranial radiotherapy (partial- or whole-brain radiotherapy) meeting all of the following criteria:
- Total dose ≥ 4,500 cGy
- Total number of fractions ≥ 25 fractions
- Dose per fraction ≥ 150 cGy
- Karnofsky performance status 60-100%
- Hemoglobin ≥ 10.0 g/dL (erythropoietin or transfusion allowed for symptomatically anemic patients with a hemoglobin < 10 g/dL)
- Creatinine ≤ 2 mg/dL
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- SGOT and SGPT ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Sexually active women of childbearing potential must use a reliable method of birth control
- It is recommended that patients use non-hormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month following treatment with armodafinil
- Prior malignancies allowed
- No baseline headaches (i.e., headaches occurring in the week before baseline assessment) of grade 4 severity (defined as severe and disabling headaches, requiring analgesics, and interfering with and preventing function or activities of daily living)
- No concurrent uncontrolled illness that may cause fatigue; interfere with drug absorption, distribution, metabolism, or excretion; or limit compliance with study requirements including, but not limited to, any of the following:
- Ongoing or active infection
- Chronic renal insufficiency
- Psychiatric illness (psychosis, psychotic disorder, history of suicide attempt, or actively suicidal)
- Extreme social situations (e.g., transportation issues that would preclude study compliance)
- Patients with a history of cardiac issues (symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) should not use armodafinil as it may cause chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG
- No history of allergic reaction attributed to modafinil or armodafinil
- No anticipated or planned excessive consumption of coffee, tea, and/or caffeine-containing beverages averaging > 600 mg of caffeine/day (i.e., approximately 6 cups of coffee/day, 12 cups of hot tea/day, or 12 cans of cola/day)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior fractionated external-beam cranial radiotherapy
- More than 30 days since prior monoamine oxidate inhibitors or investigational drugs
- More than 2 weeks since prior and no concurrent modafinil (Provigil), donepezil (Aricept), memantine hydrochloride (Namenda), methylphenidate (Ritalin), dextroamphetamine-amphetamine (Adderall), ginkgo biloba, or any other cognitive function-enhancing drugs
- At least 4 weeks since prior and no concurrent interstitial or intracavitary chemotherapy and/or radiotherapy or stereotactic radiosurgery (i.e., Gamma Knife, Linac, or Cyberknife)
- No concurrent erythropoietin, transfusion, or iron therapy (unless patient is symptomatically anemic with hemoglobin < 10 g/dL)
- Concurrent chemotherapy allowed
- Concurrent hormonal therapy for other malignancies allowed
- No concurrent non-hormonal therapy (e.g., Herceptin and other targeted agents), or cytotoxic chemotherapy
- No concurrent clopidogrel bisulfate (Plavix)
Trial Lead Organizations/Sponsors
Wake Forest University CCOP Research BaseNational Cancer Institute
|Edward G. Shaw||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01032200
ClinicalTrials.gov processed this data on October 17, 2013
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