Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents
NCT ID: NCT00825227
Last Updated: 2017-11-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2008-12-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Patient responses to 150 mg/day armodafinil
* 150 mg/day armodafinil
* taxane chemotherapy treatment alone or in combination with other agents
Armodafinil 150 mg/day
* 150 mg/day armodafinil
* concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
* patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Patient responses to placebo
* placebo
* taxane chemotherapy treatment alone or in combination with other agents
Placebo,
* placebo
* concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
* patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Interventions
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Armodafinil 150 mg/day
* 150 mg/day armodafinil
* concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
* patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Placebo,
* placebo
* concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
* patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Eligibility Criteria
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Inclusion Criteria
* The patient experiences an average score of 6 or greater for the daily worst fatigue severity assessment during screening.
* The patient has a life expectancy of at least 6 months.
* The patient is able to use the wrist actigraphy device or provide written documentation during the screening period.
* The patient has stable hemoglobin (≥10 g/dL) throughout the screening period.
* Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception (including abstinence) and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
* Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
* The patient has adequate hepatic and renal function.
* The patient meets the proposed diagnostic criteria for cancer-related fatigue as included in the International Classifications of Disease, Tenth Revision, Clinical Modification (ICD-10-CM).
* If the patient is taking any other chronic medication which may affect fatigue (e.g., antidepressants, anxiolytics, opioid analgesics), the dose has been stable for at least 4 weeks prior to screening and is expected to remain stable during the study.
Exclusion Criteria
* The patient has received concurrent stimulant medication (e.g., dextroamphetamine or methylphenidate) during the screening period or double-blind treatment period.
* The patient has received concurrent modafinil during the screening period or double-blind treatment period.
* The patient has any delay in chemotherapy treatment such that the screening period extends beyond 6 weeks.
* The patient has known central nervous system (CNS) involvement by metastatic cancer.
* The patient is receiving concurrent radiation therapy (except for palliative radiation) or treatment with another investigational agent.
* The patient has any serious, uncontrolled, non-malignant medical or psychiatric disorder that could impair the conduct of the study or the safety of the patient.
* The patient is pregnant or lactating.
* The patient has known HIV positivity.
* The patient has nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.
* The patient has uncontrolled pain.
* The patient has a known hypersensitivity to the study medication or ingredients of the study medication.
18 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Principal Investigators
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Sponsor's Medical Expert
Role: STUDY_DIRECTOR
Cephalon
Locations
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Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
Saint Joseph Medical Center
Burbank, California, United States
Compassionate Cancer Center
Fountain Valley, California, United States
Wilshire Oncology
La Verne, California, United States
Compassionate Cancer Center
Riverside, California, United States
Scripps Cancer Center
San Diego, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Southeastern Gynecologic Oncology, LLC
Atlanta, Georgia, United States
Augusta Oncology
Augusta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Summit Cancer Center
Savannah, Georgia, United States
Ingalls Cancer Research Center
Harvey, Illinois, United States
Iowa Blood and Cancer Care PLC
Cedar Rapids, Iowa, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Frederick Memorial Hospital
Frederick, Maryland, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, United States
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, United States
Montana Cancer Institute
Missoula, Montana, United States
Sparta Cancer Center
Sparta, New Jersey, United States
Forsyth Regional Cancer Center
Winton, North Carolina, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Chester County Hospital
West Chester, Pennsylvania, United States
Charleston Hematology Oncology, PA
Charleston, South Carolina, United States
C. Michael Jones
Germantown, Tennessee, United States
McLeod Cancer and Blood Center
Johnson City, Tennessee, United States
Cancer Outreach Assoc. / Outreach Clinical Trial Consortium
Abingdon, Virginia, United States
Countries
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Other Identifiers
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C10953/2036/ON/US
Identifier Type: -
Identifier Source: org_study_id