Clinical trial · Interventional
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
NCT03579446CI-TRIAL-00093065terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): \<75% participation
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrocodone | Drug | — | UNRESOLVED |
| Hydromorphone | Drug | — | UNRESOLVED |
| Levorphanol | Drug | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
| Oxycodone | Drug | — | UNRESOLVED |
| Oxymorphone | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (levorphanol, opioid regimen)
- description
- 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.
- interventionNames
- Drug: Hydrocodone
- Drug: Hydromorphone
- Drug: Levorphanol
- Drug: Morphine
- Drug: Oxycodone
- Drug: Oxymorphone
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol
- timeFrame
- Day 10 or any day after 2 days of rotation to levorphanol
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.