Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01781468
First received: January 29, 2013
Last updated: November 13, 2015
Last verified: November 2015
  Purpose
This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.

Condition Intervention Phase
Fatigue
Drug: armodafinil 150 mg
Other: Placebo
Drug: armodafinil 250 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Response rate in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue: Brief Fatigue Inventory (BFI), Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the summated score from the Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Cognitive function: As Assessed by Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association, Trail Making Test, and the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life as measured by Linear Analogue Self Assessment (LASA) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients reporting adverse events via the CTCAE version 4.0 items [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: June 2013
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
Drug: armodafinil 150 mg
given orally
Placebo Comparator: Arm II
Patients receive placebo orally every day in the morning for 8 weeks.
Other: Placebo
given orally
Experimental: Arm III
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
Drug: armodafinil 250 mg
given orally

Detailed Description:

Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue (BFI-Brief Fatigue Inventory) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.

The secondary objectives of the study are listed below.

  1. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.
  2. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.
  3. To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.
  4. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as, the relationship of fatigue and cognitive difficulties.

Patients will receive armodafinil or placebo for a total of 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy > 21 days and ≤ 24 months prior to enrollment. NOTE: Clinical stability will be defined as a stable or improved Karnofsky Performance Status (KPS) compared to the prior month.
  • ≥ 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory)
  • Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma patients. NOTE: Radiation must be completed per the second eligibility criteria, but chemotherapy is allowed.
  • Negative serum pregnancy test done ≤ 7 days prior to registration only for women determined to be of childbearing potential by the treating physician.
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, 2 or 3
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • Stable dose of corticosteroid ≥ 14 days prior to registration

Exclusion Criteria:

  • Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
  • History of hypersensitivity to other psychostimulants
  • History of steroid psychosis
  • History of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self report
  • Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc. will be excluded. Note: antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plans to continue for the duration of the trial. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.
  • Anticipating surgery, laboratory evidence of hypothyroidism with an elevated thyroid stimulating hormone (TSH) concentration in the blood > 5.0 mlU/L, profound anemia (hemoglobin level of < 10 g/dL ≤ 28 days prior to registration), or clinical depression per physician discretion.
  • Active or a history of Tourrette's syndrome or tic disorder
  • History of or active glaucoma
  • History of intractable epilepsy, or uncontrolled seizure disorder
  • Any of the following co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens:

    1. History of myocardial infarction
    2. Unstable angina
    3. Left ventricular hypertrophy
    4. Mitral valve prolapse syndrome
  • Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 3A4 (CYP3A4). Use of strong or moderate inhibitors specified in the protocol are prohibited ≤ 7 days prior to registration. See the protocol for more information.
  • Receiving any medications or substances that are inducers of CYP3A4. Use of inducers specified in the protocol are prohibited ≤ 7 days prior to registration. See the protocol for more information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781468

Contacts
Contact: Alyx B. Porter Umphrey, MD (507) 266-5230

  Hide Study Locations
Locations
United States, Alaska
Alaska Breast Care and Surgery LLC Recruiting
Anchorage, Alaska, United States, 99508
Contact: Kelly Perlewitz, MD    503-537-6040      
Alaska Women's Cancer Care Recruiting
Anchorage, Alaska, United States, 99508
Contact: Kelly Perlewitz, MD    503-537-6040      
Anchorage Oncology Centre Recruiting
Anchorage, Alaska, United States, 99508
Contact: Kelly Pelewitz, MD    503-537-6040      
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
Contact: Kelly Perlewitz, MD    503-537-6040      
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Kelly Perlewitz, MD    503-537-6040      
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: David Brachman, MD    602-240-3370      
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Alyx Umphrey, M.D.    507-538-7623      
Arizona Oncology Services Foundation Recruiting
Scottsdale, Arizona, United States, 85260
Contact: David Brachman, M.D.    602-240-3370      
United States, California
Alta Bates Summit Medical Center-Herrick Campus Recruiting
Berkeley, California, United States, 94704
Contact: Milana Dolezal, MD    510-204-3428      
Mills - Peninsula Hospitals Recruiting
Burlingame, California, United States, 94010
Contact: Milana Dolezal, MD    510-204-3428      
John Muir Medical Center-Concord Recruiting
Concord, California, United States, 95420
Contact: Marjaneh Moini, MD    925-674-2580      
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Santosh Kesari, M.D.    858-822-7524      
Saint Joseph Hospital - Orange Recruiting
Orange, California, United States, 92868
Contact: Hector Ho, MD    714-734-6220      
UC Irvine Health/Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Jose Carrillo, M.D.    714-456-5384      
Kaiser Permanente Medical Center - Santa Clara Recruiting
Santa Clara, California, United States, 95051
Contact: Tatjana Kolevska, MD    707-651-3934      
Kaiser Permanente Medical Center - Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Tatjana Kolevska, MD    707-651-3934      
United States, Colorado
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Keren Sturtz, MD    303-777-2663      
Rocky Mountain Cancer Centers-Penrose Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Keren Sturtz, MD    303-649-5469      
SCL Health Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Keren Sturtz, MD    303-649-5469      
United States, Delaware
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Gregory Masters, MD    302-366-1200      
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Gregory Masters, MD    302-366-1200      
Regional Hematology and Oncology PA Recruiting
Newark, Delaware, United States, 19713
Contact: Gregory Masters, MD    302-366-1200      
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Gregory Masters, M.D.    302-366-1200      
United States, Florida
Lakeland Regional Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Madhavi Venigalla, MD    863-904-1900      
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Deborah Heros, M.D.    305-243-1691      
Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: Thomas Sunnenberg, M.D.    850-416-4611      
United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Erin Dunbar, M.D.    404-605-3068      
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Kendal Dixon, M.D.    770-531-0093      
United States, Hawaii
Pali Momi Medical Center Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Oncare Hawaii Inc-Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
The Cancer Center of Hawaii-Leeward Recruiting
Ewa Beach, Hawaii, United States, 96706
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
The Cancer Center of Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Oncare Hawaii Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Oncare Hawaii Inc-Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
OnCare Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Samir Narayan, M.D.    734-712-3596      
Kootenai Medical Center Recruiting
Coeur D'Alene, Idaho, United States, 83814
Contact: Benjamin Marchello, MD    406-237-5470      
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin Marchello, MD    406-237-5470      
United States, Illinois
Illinois CancerCare - Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: James Wade, MD    217-876-6600      
Illinois CancerCare - Canton Recruiting
Canton, Illinois, United States, 61520
Contact: James Wade, MD    217-876-6600      
Illinois CancerCare - Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: James Wade, MD    217-876-6600      
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: James Wade, MD    217-876-6600      
Cancer Care Specialists of Central Illinois Recruiting
Decatur, Illinois, United States, 62526
Contact: James Wade, MD    217-876-6600      
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James Wade, MD    217-876-6600      
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: James Wade, MD    217-876-6600      
Illinois CancerCare - Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: James Wade, MD    217-876-6600      
NorthShore University HealthSystem-Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Ryan Merrell, M.D.    847-570-2570      
Illinois CancerCare - Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: James Wade, MD    217-876-6600      
NorthShore University HealthSystem-Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60026
Contact: Ryan Merrell, M.D.    847-570-2570      
NorthShore University HealthSystem-Highland Park Hospital Recruiting
Highland Park, Illinois, United States, 60035
Contact: Ryan Merrell, M.D.    847-570-2570      
Illinois CancerCare - Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: James Wade, MD    217-876-6600      
Illinois CancerCare - Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: James Wade, MD    217-876-6600      
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: James Wade, MD    217-876-6600      
Illinois CancerCare - Pekin Recruiting
Pekin, Illinois, United States, 61603
Contact: James Wade, MD    217-876-6600      
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61603
Contact: James Wade, M.D.    217-876-6600      
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: James Wade, M.D.    217-876-6600      
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Wade James, M.D.    217-876-6600      
Illinois CancerCare - Peru Recruiting
Peru, Illinois, United States, 61354
Contact: James Wade, MD    217-876-6600      
Illinois CancerCare - Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: James Wade, MD    217-876-6600      
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: James Wade, MD    217-876-6600      
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62703
Contact: James Wade, MD    217-876-6600      
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: James Wade, MD    217-876-6600      
Cadence Cancer Center in Warrenville Recruiting
Warrenville, Illinois, United States, 60555
Contact: Sean Grimm, MD    630-352-5450      
United States, Indiana
Michiana Hematology Oncology PC-Crown Point Recruiting
Crown Point, Indiana, United States, 46307
Contact: Robin Zon, MD    574-234-5123      
Michiana Hematology Oncology PC-Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545
Contact: Robin Zon, M.D.    574-647-6343      
Saint Joseph Regional Medical Center-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology PC-Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Robin Zon, M.D.    574-647-6343      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology PC-South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon, M.D.    574-647-6343      
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46628
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Robin Zon, M.D.    574-647-6343      
United States, Iowa
Mary Greeley Medical Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph Merchant, MD    515-956-2759      
McFarland Clinic PC - William R. Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph Merchant, M.D.    515-956-2759      
Mercy Hospital Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah Wilbur, MD    319-363-8303      
Oncology Associates at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah Wilbur, MD    319-363-8303      
Medical Oncology and Hematology Associates-West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Mehmet Copur, MD    308-398-5450      
Mercy Cancer Center-West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Mehmet Copur, MD    308-398-5450      
Alegent Health Mercy Hospital Recruiting
Council Bluffs, Iowa, United States, 51503
Contact: Mehmet Copur, MD    308-398-5450      
Medical Oncology and Hematology Associates-Laurel Recruiting
Des Moines, Iowa, United States, 50314
Contact: Mehmet Copur, MD    308-398-5450      
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Mehmet Copur, MD    308-398-5450      
Mercy Medical Center - North Iowa Recruiting
Mason City, Iowa, United States, 50401
Contact: Arvind Vemula, MD    641-428-6320      
Mercy Medical Center-West Lakes Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Mehmet Copur, MD    308-398-5450      
United States, Kansas
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas-Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker Dakhil, MD    316-262-4467      
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas-Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Main Office Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker Dakhil, M.D.    316-262-4467      
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker Dakhil, MD    316-262-4467      
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker Dakhil, MD    316-262-4467      
Associates In Womens Health Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker Dakhil, MD    316-262-4467      
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker Dakhil, MD    316-262-4467      
United States, Kentucky
Flaget Memorial Hospital Recruiting
Bardstown, Kentucky, United States, 40004
Contact: Mehmet Copur, MD    308-398-5450      
Commonwealth Cancer Center-Corbin Recruiting
Corbin, Kentucky, United States, 40701
Contact: Mehmet Copur, MD    308-398-5450      
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: John Villano, M.D.    859-323-8043      
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Firas Badin, M.D.    859-260-6295      
Saint Joseph Radiation Oncology Resource Center Recruiting
Lexington, Kentucky, United States, 40504
Contact: Mehmet Copur, MD    308-398-5450      
Saint Joseph Hospital East Recruiting
Lexington, Kentucky, United States, 40509
Contact: Mehmet Copur, MD    308-398-5450      
Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mehmet Copur, MD    308-398-5450      
Saints Mary and Elizabeth Hospital Recruiting
Louisville, Kentucky, United States, 40215
Contact: Mehmet Copur, MD    308-398-5450      
Jewish Hospital Medical Center Northeast Recruiting
Louisville, Kentucky, United States, 40245
Contact: Mehmet Copur, MD    308-398-5450      
Baptist Health Paducah Recruiting
Paducah, Kentucky, United States, 42003
Contact: Firas Badin, MD    859-260-6295      
Jewish Hospital Medical Center South Recruiting
Shepherdsville, Kentucky, United States, 40165
Contact: Mehmet Copur, MD    308-398-5450      
United States, Maine
Central Maine Medical Center Recruiting
Lewiston, Maine, United States, 04240
Contact: David Caldwell, M.D.    207-795-2935      
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Suriya Jeyapalan, MD    617-636-4341      
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Ken Zaner, M.D.    617-638-5631      
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Samir Narayan, M.D.    734-712-3596      
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert Padula, MD    616-752-6218      
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Samir Narayan, MD         
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert Padula, MD    616-752-6218      
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert Padula, MD    616-752-6218      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Gilbert Padula, M.D.    616-752-6218      
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Samir Narayan, M.D.    734-712-3596      
Lakeland Hospital Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, M.D.    574-647-6343      
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, M.D.    574-647-6343      
Providence Hospital-Southfield Cancer Center Recruiting
Southfield, Michigan, United States, 48075
Contact: Susan Lyons, MD    248-849-5337      
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Samir Narayan, M.D.    734-712-3596      
United States, Minnesota
Essentia Health Cancer Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret Friday, M.D.    218-786-3625      
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Joseph Leach, M.D.    952-993-1517      
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Alyx Umphrey, M.D.    507-538-7623      
United States, Missouri
Central Care Cancer Center - Carrie J Babb Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Contact: Jay Carlson, MD    417-820-3554      
Saint Luke's Hospital Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Donald Busiek, M.D.    314-205-6737      
Freeman Health System Recruiting
Joplin, Missouri, United States, 64804
Contact: Jay Carlson, M.D.    417-820-3554      
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jian Campian, M.D.    314-747-4241      
Mercy Hospital-Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay Carlson, M.D.    417-820-3554      
United States, Montana
Billings Clinic Cancer Center Recruiting
Billings, Montana, United States, 59107
Contact: Benjamin Marchello, MD    406-237-5470      
United States, Nebraska
CHI Health Saint Francis Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Mehmet Copur, MD    308-398-5450      
Heartland Hematology and Oncology Recruiting
Kearney, Nebraska, United States, 68845
Contact: Mehmet Copur, MD    308-398-5450      
CHI Health Good Samaritan Recruiting
Kearney, Nebraska, United States, 68847
Contact: Mehmet Copur, MD    308-398-5450      
Nebraska Cancer Research Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Gamini Soori, M.D.    402-393-3110      
Saint Elizabeth Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Mehmet Copur, MD    308-398-5450      
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131
Contact: Gamini Soori, MD    402-393-3110      
Hematology and Oncology Consultants PC Recruiting
Omaha, Nebraska, United States, 68122
Contact: Mehmet Copur, MD    308-398-5450      
Alegent Health Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Mehmet Copur, MD    308-398-5450      
Alegent Health Lakeside Hospital Recruiting
Omaha, Nebraska, United States, 68130
Contact: Mehmet Copur, MD    308-398-5450      
Alegent Health Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Mehmet Copur, MD    308-398-5450      
Midlands Community Hospital Recruiting
Papillion, Nebraska, United States, 68046
Contact: Mehmet Copur, MD    308-398-5450      
United States, New Hampshire
New Hampshire Oncology - Hematology PA Concord Recruiting
Concord, New Hampshire, United States, 03301
Contact: Douglas Weckstein, M.D.    603-622-6484      
New Hampshire Oncology Hematology PA-Hooksett Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Douglas Weckstein, M.D.    603-622-6484      
LRGHealthcare-Lakes Region General Hospital Recruiting
Laconia, New Hampshire, United States, 03246
Contact: Douglas Weckstein, M.D.    603-622-6484      
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Lara Kunschner-Ronan, MD    603-650-6312      
United States, New Jersey
Robert Wood Johnson University Hospital Somerset Recruiting
Somerville, New Jersey, United States, 08876
Contact: James Chimenti, MD    732-302-1720      
United States, New York
Hematology Oncology Associates of Central New York-East Syracuse Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey Kirshner, M.D.    315-472-7504      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Eli Diamond, MD    212-639-7576      
Highland Hospital Recruiting
Rochester, New York, United States, 14620
Contact: Yuhchyau Chen, MD    585-276-4543      
University Radiation Oncology Recruiting
Rochester, New York, United States, 14626
Contact: Yuhchyau Chen, MD    585-276-4543      
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen, MD    585-276-4543      
United States, North Carolina
Wayne Memorial Hospital Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James Atkins, M.D.    919-580-0000      
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter Watson, M.D.    252-559-2201      
United States, North Dakota
Altru Cancer Center Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Grant Seeger, MD    701-780-5860      
United States, Ohio
Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Esther Rehmus, MD    330-344-6505      
Good Samaritan Hospital - Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Mehmet Copur, MD    308-398-5450      
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Mehmet Copur, MD    308-398-5450      
TriHealth Cancer Institute-Westside Recruiting
Cincinnati, Ohio, United States, 45247
Contact: Mehmet Copur, MD    308-398-5450      
TriHealth Cancer Institute-Anderson Recruiting
Cincinnati, Ohio, United States, 45255
Contact: Mehmet Copur, MD    308-398-5450      
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: John Kuebler, M.D.    614-488-2118      
Toledo Clinic Cancer Centers-Maumee Recruiting
Maumee, Ohio, United States, 43537
Contact: Rex Mowat, MD    419-479-5605      
Saint Charles Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex Mowat    517-263-2507      
Mercy Saint Anne Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex Mowat, MD    517-263-2507      
Toledo Clinic Cancer Centers-Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex Mowat, M.D.    517-263-2507      
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: James Battiste, M.D.    405-271-8777      
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Kelly Perlewitz, MD    503-537-6040      
Legacy Mount Hood Medical Center Recruiting
Gresham, Oregon, United States, 97030
Contact: Regan Look, M.D.    503-413-7202      
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Contact: Kelly K. Perlewitz, MD    503-537-6040      
Providence Willamette Falls Medical Center Recruiting
Oregon City, Oregon, United States, 97045
Contact: Kelly Perlewitz, MD    503-537-6040      
Legacy Good Samaritan Hospital and Medical Center Recruiting
Portland, Oregon, United States, 97210
Contact: Regan Look, M.D.    503-413-7202      
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Alison Conlin, MD    503-216-6300      
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Kelly Perlewitz, MD    503-537-6040      
Kaiser Permanente Recruiting
Portland, Oregon, United States, 97227
Contact: Nagendra Moini, MD    925-674-2580      
Legacy Meridian Park Hospital Recruiting
Tualatin, Oregon, United States, 97062
Contact: Regan Look, M.D.    503-413-7202      
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, MD    610-402-7880      
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Scott Turner, M.D.    319-363-2690      
Cherry Tree Cancer Center Recruiting
Hanover, Pennsylvania, United States, 17331
Contact: Amir Tabatabai, M.D.    717-741-8124      
Geisinger Wyoming Valley/Henry Cancer Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Scott Turner, M.D.    319-363-2690      
United States, South Carolina
Greenville Health System Cancer Institute-Easley Recruiting
Easley, South Carolina, United States, 29640
Contact: David Grisell, MD    864-679-4000      
Gibbs Cancer Center-Gaffney Recruiting
Gaffney, South Carolina, United States, 29341
Contact: James Bearden, MD    864-560-6812      
Greenville Health System Cancer Institute-Andrews Recruiting
Greenville, South Carolina, United States, 29601
Contact: David Grisell, M.D.    864-241-6251      
Greenville Health System Cancer Institute-Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: David Griselle, M.D.    864-241-6251      
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: David Grisell, M.D.    864-241-6251      
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: David Grisell, MD    864-679-4000      
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: David Grisell, MD    864-679-4000      
Gibbs Cancer Center-Pelham Recruiting
Greer, South Carolina, United States, 29651
Contact: James Bearden, M.D.    864-560-6812      
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: David Grisell, M.D.    864-241-6251      
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: James Bearden, M.D.    864-560-6812      
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David Grisell, M.D.    864-241-6251      
United States, South Dakota
Avera Saint Luke's Hospital and Cancer Center Recruiting
Aberdeen, South Dakota, United States, 57401
Contact: Addison Tolentino, M.D.    913-948-5588      
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Joshua Lukenbill, MD    605-755-2301      
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Amy Krie, MD    605-322-6900      
United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Andrew Brenner, MD    210-450-5936      
United States, Utah
Huntsman Cancer Institute-University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Howard Colman, M.D.    801-585-0270      
United States, Washington
MultiCare Auburn Medical Center Recruiting
Auburn, Washington, United States, 98001
Contact: John Keech, MD    253-530-8060      
Harrison HealthPartners Hematology and Oncology-Bremerton Recruiting
Bremerton, Washington, United States, 98310
Contact: Mehmet Copur, MD    308-398-5450      
Harrison Medical Center Recruiting
Bremerton, Washington, United States, 98310
Contact: Mehmet Copur, MD    308-398-5450      
Highline Medical Center-Main Campus Recruiting
Burien, Washington, United States, 98166
Contact: Mehmet Copur, MD    308-398-5450      
Saint Elizabeth Hospital Recruiting
Enumclaw, Washington, United States, 98022
Contact: Mehmet Copur, MD    308-398-5450      
Saint Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: John Keech, MD    253-530-8060      
MultiCare Gig Harbor Medical Park Recruiting
Gig Harbor, Washington, United States, 98335
Contact: John Keech, MD    253-530-8060      
Saint Clare Hospital Recruiting
Lakewood, Washington, United States, 98499
Contact: Mehmet Copur, MD    308-398-5450      
Saint John Medical Center Recruiting
Longview, Washington, United States, 98632
Contact: Kelly Perlewitz, MD    503-537-6040      
Harrison Health Partners Hematology and Oncology - Poulsbo Recruiting
Poulsbo, Washington, United States, 98370
Contact: Mehmet Copur, M.D.    308-398-5450      
MultiCare Good Samaritan Hospital Recruiting
Puyallup, Washington, United States, 98372
Contact: John Keech, MD    253-530-8060      
Franciscan Research Center-Northwest Medical Plaza Recruiting
Tacoma, Washington, United States, 98405
Contact: Mehmet Copur, MD    308-398-5450      
Multicare-Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: John Keech, M.D.    253-530-8060      
Multicare Health System Recruiting
Tacoma, Washington, United States, 98415
Contact: John Keech, M.D.    253-530-8060      
Northwest NCI Community Oncology Research Program Recruiting
Tacoma, Washington, United States, 98405
Contact: John Keech, M.D.    253-530-8060      
Northwest Medical Specialties PLLC Recruiting
Tacoma, Washington, United States, 98405
Contact: John Keech, MD    253-530-8060      
PeaceHealth Southwest Medical Center Recruiting
Vancouver, Washington, United States, 98664
Contact: Kelly Perlewitz, MD    503-537-6040      
Legacy Salmon Creek Hospital Recruiting
Vancouver, Washington, United States, 98686
Contact: Regan Look, M.D.    503-413-7202      
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Javier Gonzalez, M.D.    304-293-3527      
United States, Wisconsin
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski, M.D.    610-402-2273      
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Anthony J. Jaslowski, MD    610-402-2273      
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Anthony J. Jaslowski, M.D.    610-402-2273      
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Michael Ojelabi, M.D.    608-782-7300      
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Ian Robins, MD    608-263-1416      
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Anthony J. Jaslowski, M.D.    610-402-2273      
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jennifer Connelly, M.D.    414-805-5207      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Alyx B. Porter Umphrey, M.D. Mayo Clinic
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01781468     History of Changes
Other Study ID Numbers: A221101  N10C3  NCI-2012-02020  U10CA037404  U10CA037447  UG1CA189823 
Study First Received: January 29, 2013
Last Updated: November 13, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on May 02, 2016