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

M.D. Anderson Cancer Center

Status and phase

Terminated

Early Phase 1

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Metastatic Malignant Solid Neoplasm

Malignant Solid Neoplasm

Treatments

Drug: Hydrocodone

Drug: Hydromorphone

Drug: Levorphanol

Drug: Oxycodone

Drug: Morphine

Other: Questionnaire Administration

Drug: Oxymorphone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03579446

2017-0925 (Other Identifier)

NCI-2018-01139 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

43 participants in 1 patient group

Supportive care (levorphanol, opioid regimen)

Experimental group

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.

Treatment: