Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain

• Status: Withdrawn
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Opioids lessen pain caused by cancer. It is not yet known whether opioids are more effective when given together with or without olanzapine in treating cancer pain.

PURPOSE: This randomized clinical trial is studying opioids to see how well they work when given together with or without olanzapine in treating patients with moderate to severe cancer pain.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Olanzapine

Criteria

DISEASE CHARACTERISTICS:

• Moderate to severe cancer pain

• Pain score ≥ 7/10 (0-10 numeric pain rating scale)

• Requires strong opioids (step 3) for pain control or are already on stable doses of step 3 opioids

• Opioid induced cognitive dysfunction or cognitive impairment, defined as cognitive disorder not otherwise specified according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) allowed

• No nonmalignant pain

• If patient has both malignant and nonmalignant pain, eligibility will be determined by the predominant site of pain

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 3 months

• Normal renal function

• Not pregnant or nursing

• Negative pregnancy test

• Must have a telephone

• Able to complete patient questionnaires alone or with assistance

• No delirium

• No hepatic dysfunction

• No nursing home patients

• No intractable nausea or vomiting

• No true allergy or intolerance to opioids

• No gastrointestinal pathology that influences absorption of opioids

• No drug seeking behavior or recent substance abuse history

• No major depression

• No respiratory compromise

• No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

• No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

PRIOR CONCURRENT THERAPY:

• More than 1 month since prior radiotherapy, chemotherapy, or radionuclides

• More than 1 month since prior bisphosphonates

• No prior surgery that influences absorption of opioids

• No concurrent therapeutic procedures or treatments that influence pain

• No concurrent active radiation or antineoplastic therapies

• No concurrent retroviral therapies

• No concurrent drugs that interfere with CYP34A, CYP1A2, or CYP2D6

• No concurrent drugs that interfere with morphine metabolism

• No concurrent medications that will influence the disposition of morphine or methadone

• No other concurrent antiemetics, antianxiety, or neuroleptic agents