RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer.

PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.

Condition	Treatment or Intervention
Depression cognitive/functional effects Quality of Life Fatigue unspecified adult solid tumor, protocol specific	Drug: modafinil  Procedure: cognitive assessment  Procedure: fatigue assessment/management  Procedure: psychosocial assessment/care  Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

OBJECTIVES: Primary

• Determine the safety of modafinil in cancer patients.
• Determine the efficacy of this drug, in terms of improving fatigue, in these patients.

Secondary

• Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients.

OUTLINE: This is a nonrandomized, pilot study.

Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive additional modafinil at the discretion of the physician.

Fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study within 9 months.

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

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer
• Brief Fatigue Inventory score ≥ 4

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 1-3

Life expectancy

• At least 2 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No history of left ventricular hypertrophy
• No history of ischemic ECG changes
• No history of chest pain
• No history of arrhythmia
• No history of other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use

Other

• Not pregnant or nursing
• Negative pregnancy test
• Thyroid stimulating hormone normal
• No known hypersensitivity to modafinil
• No history of psychotic disorder and/or active psychosis
• No history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• Concurrent thalidomide allowed

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Concurrent narcotics, phenothiazines, or benzodiazepines allowed
• No other concurrent investigational therapy

Please refer to this study by ClinicalTrials.gov identifier  NCT00112515

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting

Study chairs or principal investigators

Leslie Blackhall, MD,  Principal Investigator,  University of Virginia, Health Sciences Center Cancer Center   

Study ID Numbers:  CDR0000432953; UVACC-HIC-10951; UVACC-30603
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112515
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07