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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Fatigue, Chemotherapy Side Effects

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome 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

Outcome Description:

Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.

Outcome Time Frame:

Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)

Safety Issue:

No

Principal Investigator

Sponsor's Medical Expert

Investigator Role:

Study Director

Investigator Affiliation:

Cephalon

Authority:

United States: Food and Drug Administration

Study ID:

C10953/2036/ON/US

NCT ID:

NCT00825227

Start Date:

December 2008

Completion Date:

February 2010

Related Keywords:

  • Fatigue
  • Chemotherapy Side Effects
  • Cancer
  • Fatigue
  • Taxanes
  • Fatigue

Name

Location

Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Mount Nittany Medical CenterState College, Pennsylvania  16803
Chester County HospitalWest Chester, Pennsylvania  19380
Washington Cancer InstituteWashington, District of Columbia  20010
Medical College of GeorgiaAugusta, Georgia  30912
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Cancer Care AssociatesTulsa, Oklahoma  74136
Scripps Cancer CenterLa Jolla, California  92037
Hematology Oncology Centers of the Northern RockiesBillings, Montana  59101
Frederick Memorial HospitalFrederick, Maryland  21701
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Iowa Blood and Cancer Care PLCCedar Rapids, Iowa  52402
Charleston Hematology Oncology, PACharleston, South Carolina  29403
Forsyth Regional Cancer CenterWinston-Salem, North Carolina  27103
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
McLeod Cancer and Blood CenterJohnson City, Tennessee  37604
Compassionate Cancer CenterFountain Valley, California  92708
Southeastern Gynecologic Oncology, LLCAtlanta, Georgia  30342
Park Nicollet InstituteSt Louis Park, Minnesota  55416
Saint Joseph Medical CenterBurbank, California  91505
Sparta Cancer CenterSparta, New Jersey  07871
Augusta OncologyAugusta, Georgia  30901
Wilshire OncologyLa Verne, California  91750
Summit Cancer CenterSavannah, Georgia  31405
Ingalls Cancer Research CenterHarvey, Illinois  60426
Montana Cancer InstituteMissoula, Montana  59802
C. Michael JonesGermantown, Tennessee  38138
Cancer Outreach Assoc. / Outreach Clinical Trial ConsortiumAbingdon, Virginia  24211