Clinical trial NCT00825227: Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Armodafinil Treatment (150 mg/Day) for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fatigue
Chemotherapy Side Effects
Keywords: Cancer
Fatigue
Taxanes
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents

Detailed description: The primary objective of study was to determine whether armodafinil treatment at a dose of 150 mg/day is more effective than placebo treatment in reducing fatigue in patients receiving taxane chemotherapy alone or in combination with other agents by comparing the change from Screening cycle to treatment cycle (cycle 2) in the patient's average daily rating of their worst fatigue severity during the past 24 hours. In addition, the change in the percentage of days with severe fatigue and the mean Brief Fatigue Inventory scores were to be recorded.

Eligibility criteria: Key Inclusion Criteria:

* The patient has cancer and is receiving, or is scheduled to receive, taxane chemotherapy (paclitaxel, docetaxel, or albumin-bound paclitaxel), either alone or in combination with other agents.
* 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.

Key Exclusion Criteria:

* The patient has any untreated reversible medical condition which may cause fatigue (e.g., metabolic disturbance, infection, endocrine abnormalities).
* 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.

Primary outcomes:
measure: Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire
timeFrame: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)
Secondary outcomes:
measure: Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire
timeFrame: Duration of up to 8 weeks total (Screening and Double-Blind)
measure: Change in the Brief Fatigue Inventory (BFI) Global Score
timeFrame: Duration of up to 8 weeks total (Screening and Double-Blind)
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Burbank
country: United States
facility: Saint Joseph Medical Center
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Center
state: California
city: La Verne
country: United States
facility: Wilshire Oncology
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Center
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: Washington, D.C.
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Atlanta
country: United States
facility: Southeastern Gynecologic Oncology, LLC
state: Georgia
city: Augusta
country: United States
facility: Augusta Oncology
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Center
state: Georgia
city: Harvey
country: United States
facility: Ingalls Cancer Research Center
state: Illinois
city: Cedar Rapids
country: United States
facility: Iowa Blood and Cancer Care PLC
state: Iowa
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute
state: Minnesota
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies
state: Montana
city: Missoula
country: United States
facility: Montana Cancer Institute
state: Montana
city: Sparta
country: United States
facility: Sparta Cancer Center
state: New Jersey
city: Winton
country: United States
facility: Forsyth Regional Cancer Center
state: North Carolina
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: State College
country: United States
facility: Mount Nittany Medical Center
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology, PA
state: South Carolina
city: Germantown
country: United States
facility: C. Michael Jones
state: Tennessee
city: Johnson City
country: United States
facility: McLeod Cancer and Blood Center
state: Tennessee
city: Abingdon
country: United States
facility: Cancer Outreach Assoc. / Outreach Clinical Trial Consortium
state: Virginia
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References: