NCT03579446

Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer

Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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. 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, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Hydrocodone	Given by PO
DRUG	Hydromorphone	Given by PO
DRUG	Levorphanol	Given PO
DRUG	Morphine	Given by PO
DRUG	Oxycodone	Given by PO
DRUG	Oxymorphone	Given by PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-11-29
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2018-07-06
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study