Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents

PHASE2TerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

February 28, 2010

Conditions
FatigueChemotherapy Side Effects
Interventions
DRUG

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"

DRUG

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"

Trial Locations (29)

16803

Mount Nittany Medical Center, State College

17822

Geisinger Medical Center, Danville

17871

Sparta Cancer Center, Sparta

19380

Chester County Hospital, West Chester

20010

Washington Cancer Institute, Washington D.C.

20817

Center for Cancer and Blood Disorders, Bethesda

21701

Frederick Memorial Hospital, Frederick

24211

Cancer Outreach Assoc. / Outreach Clinical Trial Consortium, Abingdon

27103

Forsyth Regional Cancer Center, Winton

29403

Charleston Hematology Oncology, PA, Charleston

30342

Southeastern Gynecologic Oncology, LLC, Atlanta

30901

Augusta Oncology, Augusta

30912

Medical College of Georgia, Augusta

31405

Summit Cancer Center, Savannah

32256

Integrated Community Oncology Network, Jacksonville

35661

Northwest Alabama Cancer Center, Muscle Shoals

37604

McLeod Cancer and Blood Center, Johnson City

38138

C. Michael Jones, Germantown

52402

Iowa Blood and Cancer Care PLC, Cedar Rapids

55426

Park Nicollet Institute, Saint Louis Park

59101

Hematology Oncology Centers of the Northern Rockies, Billings

59802

Montana Cancer Institute, Missoula

60426

Ingalls Cancer Research Center, Harvey

74136

Cancer Care Associates, Tulsa

91505

Saint Joseph Medical Center, Burbank

91750

Wilshire Oncology, La Verne

92123

Scripps Cancer Center, San Diego

92501

Compassionate Cancer Center, Riverside

92708

Compassionate Cancer Center, Fountain Valley

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY

NCT00825227 - Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents | Biotech Hunter | Biotech Hunter