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

Alternate Title

Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

Basic Trial Information

Objectives

Primary

1. To compare the effectiveness of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone) in controlling pain (i.e., analgesia) in patients with cancer.

Secondary

1. To compare the tolerability of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone).
2. To identify a subset of patients most likely to benefit from an opioid rotation to oral methadone, in terms of significant improvement in pain control or opioid tolerability.

Entry Criteria

Disease Characteristics:

• Receiving ongoing care in the outpatient medical oncology setting

• Self-reported pain (of any cause) for which long-acting strong opioids (morphine or oxycodone) have been prescribed or administered
  • Oral morphine-equivalent daily dose (MEDD) of existing opioid regimen (long-acting or immediate-release) 40-300 mg/day

• Worst pain score on a scale of 0 (no pain) to 10 (worst pain) of ≥ 5 for ≥ 1 week duration based on verbal self-report AND/OR ≥ 1 persistently bothersome symptom attributed to an opioid side effect (e.g., fatigue, confusion, depressed level of consciousness, memory loss, personality change, anorexia, constipation, dehydration, nausea, vomiting, weight loss, pruritus, urticaria, impotence, reduced libido, and urinary retention or hesitancy)

Prior/Concurrent Therapy:

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy or surgery for local control of cancer or pain palliation
• More than 60 days since prior use of the same long-acting opioid (i.e., the new long-acting opioid) that patient is switching to on the study
• More than 12 weeks since prior methadone therapy
• More than 3 days since prior and no concurrent transdermal fentanyl, oxymorphone, or buprenorphine
• Concurrent systemic anticancer therapy or bisphosphonates allowed provided therapy was initiated ≥ 4 weeks ago
• Concurrent tricyclic antidepressants, NSAIDs, anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated ≥ 2 weeks ago
  • Dose expected to remain stable until after the first week of opioid rotation on study
• No concurrent methadone maintenance therapy for opioid addiction
• No concurrent intrathecal infusion of analgesics
• No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)

Patient Characteristics:

• None of the following conditions that could predispose the patient to prolonged QT interval-associated tachycardia:
  • Serum potassium < 3.0 mg/dL
  • Cocaine abuse within the past 3 months
  • Family history of sudden death
  • Advanced heart failure (ejection fraction < 40% and/or NYHA class III or IV heart disease)
• No known or suspected cognitive impairment that could interfere with adherence to the medication plan or self-report of symptoms and side effects
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

Outcomes

At least a 3-point reduction in pain score on the M.D. Anderson Symptom Inventory (MDASI)

30% reduction in patients’ total summary score for the individual composite drug toxicity score (CDTS) items
Identification of a subset of patients most likely to benefit from an opioid rotation to oral methadone, in terms of significant improvement in pain control or opioid tolerability

Outline

This is a multicenter study. Patients are stratified according to their baseline opioid (morphine vs oxycodone). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients are switched from their current opioid medication (oxycodone or morphine) to methadone. Patients receive oral methadone 2-3 times daily for 4 weeks.

• Arm II: Patients currently receiving oxycodone are switched to sustained-release (SR) morphine. Patients currently receiving morphine are switched to SR oxycodone. Patients receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.

Patients are assessed for pain control and complete a symptom questionnaire on days 1, 8, 15, 22, and 28.

Trial Contact Information

Trial Lead Organizations

University of Texas M.D. Anderson CCOP Research Base

Michael Fisch, MD, MPH, FACP, Protocol chair		Ph: 713-563-9905
James Bearden, MD, Protocol co-chair		Ph: 864-560-6812 Email: jbearde@srhs.com

Registry Information
Official Title		A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients with Pain Management Problems: The "Simply Rotate" Study
Trial Start Date		2009-03-10
Trial Completion Date		2010-09-08
Registered in ClinicalTrials.gov		NCT00726830
Date Submitted to PDQ		2008-06-12
Information Last Verified		2010-09-13

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