Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

James P. Wilmot Cancer Center at University of Rochester Medical Center

Gary R. Morrow

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00042848
Information obtained from ClinicalTrials.gov on December 14, 2011

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