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Hematopoietic and Lymphoid Cell NeoplasmEarly Phase 1NCT03579446

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

A Early Phase 1 study testing Hydrocodone, Hydromorphone and Levorphanol in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hydrocodone, Hydromorphone and Levorphanol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited States
Study dates
29 Nov 2018to 15 Jun 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol at the primary end point.

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

Being tested
Hydrocodone, Hydromorphone, Levorphanol, Morphine, Oxycodone
Medical subject headings
Hematologic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydrocodoneDrug

    Given by PO

  • HydromorphoneDrug

    Also called (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

    Given by PO

  • LevorphanolDrug

    Given PO

  • MorphineDrug

    Given by PO

  • OxycodoneDrug

    Also called Oxycodone SR

    Given by PO

  • OxymorphoneDrug

    Given by PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03579446
Study groupRoleWhat they receive
Supportive care (levorphanol, opioid regimen)ExperimentalPatients 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.
Receives: Drug: Hydrocodone; Drug: Hydromorphone; Drug: Levorphanol; Drug: Morphine; Drug: Oxycodone; Drug: Oxymorphone; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Opioid rotation ratio (ORR)

    Will be calculated by levorphanol mg (day 10 +/- 1) over MEDD (day 0). ORR will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be applied to examine the difference on ORR between/among patients' characteristics groups.

    Measured: Up to 30 days

  2. Change of Edmonton Symptom Assessment Scale (ESAS) pain score

    Pain score change will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be applied to examine the difference on pain score change between/among patients' characteristics groups. Since ESAS pain score will be measured daily from day 0 to day 10 +/- 1 and on day 30 +/- 3, mixed model will be applied to examine the differential changes over time for ESAS pain score, adjusting for other covariates of interest. ORR and baseline MEDD will be presented by scatter plots. Correlation will be assessed between levorphanol dose on day 10 +/- 1, ORR and baseline MEDD suing Pearson or Spearman correlation coefficient when appropriate. Linear regression models will be applied to estimate the linear association between levorphanoal dose on day 10 +/- 1, ORR and baseline MEDD.

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

  3. Incidence of levorphanol related side effects

    Will be rated using the Opioid Side Effect Scale on xerostmia, nauseas, constipation, drowsiness and confusion daily from day 0 to day 10 +/-1 and on day 30 +/- 3.

    Measured: Up to day 30

  4. Personalized pain goal (PPG)

    PPG will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Mixed model will be applied to examine the differential changes over time for opioid side effect scale, adjusting for other covariates of interest. The goal is not achieved if the PPG is lower than the ESAS pain score. Frequency and proportion of achieved goal will be summarized.

    Measured: Up to day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start29 Nov 2018
  3. Primary completion15 Jun 2023
  4. Study completion15 Jun 2023

Why it stopped: \<75% participation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03579446
Sponsor's protocol ID
2017-0925
Other IDs
NCI-2018-01139, 2017-0925
Status last verified
Jul 2025
First submitted
25 Jun 2018
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Hydrocodone, Hydromorphone and Levorphanol in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: \<75% participation). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol (time frame: Day 10 or any day after 2 days of rotation to levorphanol). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

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