Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Theophylline in Treating Cancer Patients With Shortness of Breath

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	16 and over		CAN-NCIC-SC14 NCT00003684, SC14

Objectives

I.  Determine whether theophylline will improve the dyspnea rating of patients 
with cancer who are short of breath and have evidence of respiratory muscle 
weakness.

II.  Determine whether this drug will improve the ability to perform daily 
activities in this group of patients.

III.  Determine whether this drug will improve objective measures of lung 
function (e.g., FEV-1, FVC) and maximum inspiratory pressure in these patients.

IV.  Determine whether the serum theophylline level is related to the 
magnitude of the effect that is observed in this patient population.

V.  Determine whether this drug will improve a global rating of quality of 
life in this patient group.

Entry Criteria

Disease Characteristics:

Histologically or cytologically proven diagnosis of cancer

FEV-1/FVC at least 80% of predicted OR
FEV-1/FVC less than 80% AND improvement in FEV-1 less than 15% after using a
bronchodilator

Maximum inspiratory pressure no greater than -50 cm of water

Oximetry at least 90%

Rating of dyspnea "moderate" or "severe" on verbal rating scale (VRS) of
"none, mild, moderate, or severe" to describe "usual breathlessness" when
walking over the past 24 hours

Score for pain of "none" or "mild" on a VRS of "none, mild, moderate, or
severe" for "unusual pain" over the past 24 hours

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 At least 14 days since prior chemotherapy
 No concurrent chemotherapy

Endocrine therapy:
 At least 2 months since prior initiation of hormonal therapy 
  Hormones as appetite stimulant allowed if received for more than 2 weeks
 No concurrent oral contraceptives
 Concurrent steroids allowed if taken for at least 1 week prior to study
 Concurrent inhaled or oral corticosteroids allowed if taken for at least 1
  week prior to study
 No concurrent initiation of a new hormonal manipulation
Radiotherapy:
 At least 28 days since prior radiotherapy that includes the lung in the
  treatment field
 No concurrent radiotherapy that includes the lung in the treatment field

Surgery:
 Not specified

Other:
 No concurrent digitalis glycosides, lithium, coumarin anticoagulants, other
  xanthines, cimetidine, quinolone antibiotics (e.g, ciprofloxacin and
  norfloxacin), macrolide antibiotics (e.g., erythromycin), fluvoxamine, and
  calcium channel blockers
 Concurrent nebulized or inhaled cromolyn, nedocromil, beta2-agonists,
  ipratropium, opioids, benzodiazepines, oxygen, and diuretics allowed if dose
  is stable for more than 1 week prior to study
 No concurrent paracentesis (i.e., thoracentesis)
 No concurrent blood transfusion

Patient Characteristics:

Age:
 16 and over

Performance status:
 Not specified

Life expectancy:
 Greater than 10 days

Hematopoietic:
 Hemoglobin at least 8.5 g/dL

Hepatic:
 AST/ALT no greater than 2 times upper limit of normal (ULN)
 No liver disease

Renal:
 Creatinine no greater than 2 times ULN
 No kidney disease

Cardiovascular:
 No acute congestive heart failure
 Greater than 3 months since prior myocardial infarction
 No coronary artery disease where cardiac stimulation might prove harmful
  (i.e., no unstable angina)
 No uncontrolled hypertension

Pulmonary:
 See Disease Characteristics

Other:
 Folstein Mini-Mental Status Exam score of at least 24
 Able (i.e., sufficiently fluent) and willing to complete quality of life
  questionnaire and other assessments in either English or French
 No history of clinically significant allergy or intolerance to theophylline,
  aminophylline, or other methylxanthines
 No active peptic ulcer disease
 No uncontrolled hyperthyroidism

Expected Enrollment

A total of 60 patients (30 in each arm) will be accrued for this study.

Outline

This is a randomized, double blind, multicenter study.  Patients are 
stratified according to those who can complete a 6 minute walking test versus 
those who cannot.

Patients receive either oral theophylline or placebo once daily for 3 days.  
In the absence of dose limiting toxicity (DLT), patients receive an increased 
dose for an additional 4 days.  In the presence of DLT, patients receive a 
decreased dose or treatment is stopped.  Following completion of the 7 day 
study period, patients may be given the option to continue on active drug or 
placebo for 1 additional month unless toxic side effects develop.

Quality of life is assessed on days 1 and 8 and at the end of the additional 1 
month period.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Deborah Dudgeon, MD, RN, Protocol chair		Ph: 613-548-2485

Registry Information
Official Title		A Phase III Double-Blind Study of Theophylline Versus Placebo for the Treatment of Dyspnea in Cancer Patients
Trial Start Date		1998-03-24
Registered in ClinicalTrials.gov		NCT00003684
Date Submitted to PDQ		1998-12-04
Information Last Verified		2007-05-31

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