RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known.

PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.

Condition	Treatment or Intervention	Phase
Fatigue unspecified adult solid tumor, protocol specific	Drug: modafinil  Procedure: fatigue assessment/management  Procedure: supportive care/therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Assess the degree to which modafinil can reduce fatigue in cancer patients receiving chemotherapy.
• Assess the relationship between depression and fatigue in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Beginning on day 5 of the second course of chemotherapy, patients receive oral modafinil once daily.
• Arm II: Beginning on day 5 of the second course of chemotherapy, patients receive oral placebo once daily. Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of disease progression or unacceptable toxicity.

Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy.

PROJECTED ACCRUAL: A total of 837 patients will be accrued for this study within approximately 2.5 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer
• Concurrently receiving or has previously received chemotherapy and is scheduled for at least 3 additional courses of chemotherapy
• Each course of chemotherapy must be at least 2 weeks in duration
• No concurrent radiotherapy or interferon therapy
• Brief Fatigue Inventory question #3 "fatigue worst" score of 2 or greater 1 week after first chemotherapy course

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Not specified

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• No uncontrolled anemia

Renal

• Not specified

Cardiovascular

• No history of clinically significant cardiac disease, including any of the following:
• Unstable angina
• Left ventricular hypertrophy
• Ischemic echocardiogram changes
• Chest pain
• Arrhythmia
• Other clinically significant manifestations of mitral valve prolapse in association with use of CNS stimulants (e.g., caffeine, amphetamines, or methylphenidate)
• No uncontrolled hypertension

Gastrointestinal

• Able to swallow medication
• No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract

Other

• No severe headaches
• No glaucoma
• No seizure disorder
• No narcolepsy
• No psychotic disorder
• No Tourette's syndrome
• No alcohol or drug abuse
• Not pregnant or nursing
• Fertile patients must use effective barrier contraception during and for at least 1 full menstrual cycle after study completion

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• No concurrent chronic corticosteroids

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Other

• No prior modafinil
• At least 30 days since prior regular use of psychostimulants (e.g., amphetamines, methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs)
• No concurrent alcohol
• Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed
• Concurrent phenytoin allowed
• Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily) for maintenance of venous access devices allowed

Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36607,  United States; Recruiting
Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
Colorado
      Boulder Community Hospital, Boulder,  Colorado,  80301-9019,  United States; Recruiting
      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States; Recruiting
      Hope Cancer Care Center at Longmont United Hospital, Longmont,  Colorado,  80501,  United States; Recruiting
      Medical Center of Aurora - South Campus, Aurora,  Colorado,  80012-0000,  United States; Recruiting
      Penrose Cancer Center at Penrose Hospital, Colorado Springs,  Colorado,  80933,  United States; Recruiting
      Porter Adventist Hospital, Denver,  Colorado,  80210,  United States; Recruiting
      Presbyterian - St. Luke's Medical Center, Denver,  Colorado,  80218,  United States; Recruiting
      Rocky Mountain Cancer Centers - Denver Rose, Denver,  Colorado,  80220,  United States; Recruiting
      Rocky Mountain Cancer Centers - Thornton, Thornton,  Colorado,  80229,  United States; Recruiting
      Sky Ridge Medical Center, Lone Tree,  Colorado,  80124,  United States; Recruiting
      St. Joseph Hospital, Denver,  Colorado,  80218-1191,  United States; Recruiting
      St. Mary-Corwin Regional Medical Center, Pueblo,  Colorado,  81004,  United States; Recruiting
      Swedish Medical Center, Englewood,  Colorado,  80112,  United States; Recruiting
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States; Recruiting
New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States; Recruiting
North Carolina
      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States; Recruiting
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting

Study chairs or principal investigators

Gary R. Morrow, PhD, MS,  Study Chair,  James P. Wilmot Cancer Center   

Study ID Numbers:  CDR0000069477; URCC-U2901; NCI-5952; NCI-P02-0228; NCT00042848
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  August 5, 2002
ClinicalTrials.gov Identifier:  NCT00042848
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08