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

NCT03579446 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: 2017-0925NCI-2018-01139
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol

  Bayesian methodology developed by Peter Thall will be used to monitor the study. This method decides whether levorphanol is promising relative to the standard medicine. Will estimate the proportion of successful opioid rotation along with a 95% confidence interval. Association between successful opioid rotation and demographic/clinical characteristics will be examined by Chi-squared test or Fisher's exact test when appropriate. Logistic regression model will be employed to assess the effect of demographic/clinical characteristics on the presence of successful opioid rotation.

  Day 10 or any day after 2 days of rotation to levorphanol

Secondary Outcomes (4)

• Opioid rotation ratio (ORR)

  Up to 30 days

• Change of Edmonton Symptom Assessment Scale (ESAS) pain score

  Baseline up to day 10 or any day after 2 days of rotation to levorphanol

• Incidence of levorphanol related side effects

  Up to day 30

• Personalized pain goal (PPG)

  Up to day 30

Study Arms (1)

Supportive care (levorphanol, opioid regimen)

EXPERIMENTAL

Patients receive levorphanol 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.

Drug: Hydrocodone; Drug: Hydromorphone; Drug: Levorphanol; Drug: Morphine; Drug: Oxycodone; Drug: Oxymorphone; Other: Questionnaire Administration

Interventions

Hydrocodone DRUG

Given by PO

Supportive care (levorphanol, opioid regimen)

Hydromorphone DRUG

Given by PO

Also known as: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

Supportive care (levorphanol, opioid regimen)

Levorphanol DRUG

Given PO

Supportive care (levorphanol, opioid regimen)

Morphine DRUG

Given by PO

Supportive care (levorphanol, opioid regimen)

Oxycodone DRUG

Given by PO

Also known as: Oxycodone SR

Supportive care (levorphanol, opioid regimen)

Oxymorphone DRUG

Given by PO

Supportive care (levorphanol, opioid regimen)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (levorphanol, opioid regimen)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seen in the SCC or Pain Clinic with a diagnosis of cancer with or without evidence of metastatic disease
• Diagnosis of cancer related pain currently treated with first line strong oral opioid analgesics such as morphine, oxycodone, oxymorphone, hydromorphone or hydrocodone
• Age 18 or older
• Able to complete study assessments
• Individual is willing to sign written informed consent
• Patients who are classified as being opioid tolerant by receiving a baseline MEDD of \>= 60 mg
• Patients who are local and able to follow-up in the SCC or Pain Clinic within 30 days if necessary
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 3

You may not qualify if:

• Cognitive impairment with a Memorial Delirium Assessment Scale (MDAS) score of 7 or higher or diagnosed with neurocognitive impairment by the treating SCC or Pain Clinic physician
• Renal insufficiency defined as estimated glomerular filtration rate of \< 60
• Hepatic insufficiency defined as transaminitis (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \> 3 times the highest normal value) or hyperbilirubinemia of \> 1.5 times the highest normal value
• Non-English speaking participants as not all assessments are validated in other languages
• Presence of neuropathic pain as a primary pain syndrome
• Non-malignant pain
• Patients with history of alcohol or substance abuse by using Cut-down, Annoyed, Guilty, Eye-opener adapted to include Drug use questionnaire (CAGE-AID) score of 2 or higher; Pain Clinic: Screener and Opioid Assessment for Patients with Pain (SOAPP) score of 7 or higher. In the unlikely event that CAGE-AID or SOAPP is not present in patient's chart, a CAGE-AID questionnaire will be administered after obtaining verbal consent for screening
• Patients receiving methadone due to reasons such as long and variable half-life
• Patients receiving scheduled benzodiazepines due to the risk of excessive sedation
• Patients with a MEDD of \> 300
• Unable or unwilling to sign consent

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasm Metastasis

Interventions

Hydrocodone; Hydromorphone; Levorphanol; Morphine; Oxycodone; Oxymorphone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Akhila S Reddy

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: November 29, 2018
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

US (1)