Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed 18 and over NCOG-0N841 NCOG-0N-84-1

Objectives

I.  Compare, in a carefully controlled environment, the first-dose analgesic 
efficacy of 10 mg ketorolac with that of acetaminophen plus codeine and with 
that of a placebo in patients with cancer pain.
II.  Determine and compare the analgesic effectiveness of ketorolac vs. 
acetaminophen plus codeine when given for up to seven days.
III.  Characterize the pattern of usage and patient acceptance of ketorolac 
vs. acetaminophen plus codeine when taken for up to seven days on a 
recommended 4-times-per-day basis.
IV.  Determine and compare the side effects, if any, of the study drugs.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with a histologically confirmed diagnosis of cancer who are experiencing 
initial pain of moderate or severe intensity that is felt to be secondary to 
the cancer, as determined by uniformly conducted interviews by a trained 
observer.  Patients must have had pain, or required regular analgesics for 
pain, for at least 1 month prior to enrollment and must be expected by the 
investigator to have pain, if untreated, for at least 7 more days.  A platelet 
count of at least 100,000 is required, and there may be no known coagulopathy. 
 Patients must be well oriented, cooperative, and able to communicate 
appropriately with their doctor or nurse and must be able to take oral 
medications.  Patients receiving chemotherapy or radiotherapy may be entered, 
provided their hematologic and other organ systems are stabilized and the 
overall clinical response is as anticipated by the investigator for the 
regimen of the treatment used.  A history of narcotic use at the usually 
recommended dose is allowed provided the patient consents to abstain from 
further narcotic use during the study.  Patients who have received methadone 
within 6 hours or other analgesics within 4 hours of the administration of the 
first dose of study medication are excluded, as are patients who have taken, 
within 4 hours of the first dose of study drug, any other medications that may 
potentially interfere with the study medication (e.g., benzodiazepines, 
barbiturates, phenothiazines, or tricyclic antidepressants).  In general, any 
concomitant medical condition that would compromise the patient's ability to 
absorb, metabolize, or excrete the study medications precludes entry; 
specifically, the following medical conditions exclude:  peptic ulcer, 
ulcerative colitis, convulsive disorders, severe cardiovascular disease, blood 
dyscrasia, alcoholism, severe unstable diabetes, severe liver dysfunction 
(alkaline phosphatase, SGOT, SGPT, or bilirubin more than twice normal), or 
severe kidney dysfunction (creatinine greater than 2.0 mg%).  Patients with 
rapid disease progression or anticipated rapid tumor response from concurrent 
antitumor treatment that would confound the determination of side effects 
from, tolerance to, or analgesic efficacy of the study medications are 
excluded; patients with known gastrointestinal lesions and abdominal pain will 
not be included in the study because of the difficulty in distinguishing 
gastrointestinal dysfunction and abdominal pain attributable to abdominal 
cancers from possible side effects of the study drugs.  Patients who are 
sensitive and/or allergic to acetaminophen, codeine, aspirin, or other similar 
drugs are excluded, as are those who are pregnant, lactating, or of 
childbearing potential and not practicing an effective method of contraception.

Expected Enrollment

A total of approximately 150 patients (50 per arm) will be accrued over 12-15 
months.

Outline

Randomized, double-blind study.  Patients randomized to Arm III will receive 
their first dose on that arm and will then be randomized for further treatment 
on Arms I and II.
Arm I:  Single-agent Analgesia plus Placebo.  Ketorolac trimethamine, 
Ketorolac; plus Placebo.
Arm II:  2-Drug Combination Analgesia.  Acetaminophen; Codeine (Tylenol-3 
capsules).
Arm III:  Placebo.

Trial Contact Information

Trial Lead Organizations

Clinical Research Program - Northern California Cancer Center

Robert Carlson, MD, Protocol chair		Ph: 650-725-6457; 800-756-9000