Last updated on February 2020

Levorphanol as a Second Line Opioid in Cancer Patients


Brief description of study

This early phase I trial studies how well levorphanol works as a second line opioid in reducing pain in patients with cancer that may have spread to other places in the body. Levorphanol may work better in controlling cancer pain. The primary end point is either at day 10 +/- 1 or any day after 2 days of rotation to levorphanol if the patient reaches his/her baseline personalized pain goal (PPG) in situations where opioid rotation is performed due to uncontrolled pain and </= 4 breakthrough opioid doses are used.

Detailed Study Description

PRIMARY OBJECTIVE:

I. To determine the proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol at the primary end point. to levorphanol at the primary end point. The primary end point is either at day 10 +/- 1 or any day after 2 days of rotation to levorphanol if the patient reaches his/her baseline personalized pain goal (PPG) in situations where opioid rotation is performed due to uncontrolled pain and less than or equal to 4 breakthrough opioid doses are used.

SECONDARY OBJECTIVES:

I. To determine the median opioid rotation ratio (ORR) in patients undergoing successful opioid rotations from morphine equivalent daily dose (MEDD) to levorphanol in the Supportive Care Center (SCC) or Pain Clinic.

II. To determine the effect of levorphanol on cancer pain (as measured by change in Edmonton Symptom Assessment System's [ESAS] pain item from baseline) in cancer outpatients undergoing opioid rotation to levorphanol at the primary end point of treatment.

III. To determine the association between the opioid rotation ratio from MEDD to levorphanol and baseline MEDD prior to opioid rotation.

IV. Measure levorphanol related side effects using the opioid side effect scale at day 10 +/- 1 of starting levorphanol.

V. Determine what percentage of patients rotated to levorphanol achieve their personalized pain goal.

VI. Determine the predictors of successful opioid rotation from other opioids to levorphanol.

OUTLINE

Patients receive levorphanol orally (PO) every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine sulfate, hydromorphone hydrochloride, oxycodone, and oxymorphone hydrochloride for breakthrough pain.

Clinical Study Identifier: NCT03579446

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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