Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

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.

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 central nervous system 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