Levorphanol as a Second Line Opioid in Cancer Patients
Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study
| Sponsors |
Lead Sponsor: M.D. Anderson Cancer Center Collaborator: National Cancer Institute (NCI) |
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| Source | M.D. Anderson Cancer Center | ||||||||||
| 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. The primary end point is either at day 10 +/- 1 or any day after 2 days of rotation to levorphanol if the patient reaches his/her baseline personalized pain goal (PPG) in situations where opioid rotation is performed due to uncontrolled pain and |
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| 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. to levorphanol at the primary end point. The primary end point is either at day 10 +/- 1 or any day after 2 days of rotation to levorphanol if the patient reaches his/her baseline personalized pain goal (PPG) in situations where opioid rotation is performed due to uncontrolled pain and less than or equal to 4 breakthrough opioid doses are used. 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 sulfate, hydromorphone hydrochloride, oxycodone, and oxymorphone hydrochloride for breakthrough pain. |
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| Overall Status | Recruiting | ||||||||||
| Start Date | November 29, 2018 | ||||||||||
| Completion Date | January 16, 2021 | ||||||||||
| Primary Completion Date | January 16, 2021 | ||||||||||
| Phase | Early Phase 1 | ||||||||||
| Study Type | Interventional | ||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 86 | ||||||||||
| Condition | |||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Hydrocodone Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Intervention Type: Drug Intervention Name: Hydromorphone Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Intervention Type: Drug Intervention Name: Hydromorphone Hydrochloride Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Intervention Type: Drug Intervention Name: Levorphanol Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Intervention Type: Drug Intervention Name: Morphine Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Intervention Type: Drug Intervention Name: Morphine Sulfate Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Intervention Type: Drug Intervention Name: Oxycodone Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Other Name: Oxycodone SR Intervention Type: Drug Intervention Name: Oxymorphone Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Intervention Type: Drug Intervention Name: Oxymorphone Hydrochloride Description: Given PO Arm Group Label: Supportive care (levorphanol, opioid regimen) Intervention Type: Other Intervention Name: Questionnaire Administration Description: Ancillary studies Arm Group Label: Supportive care (levorphanol, opioid regimen) |
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| Eligibility |
Criteria:
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 - 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 - Able to swallow oral medication 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 or 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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Overall Official |
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| Overall Contact |
Last Name: Akhila Reddy Phone: 713-745-2668 Email: [email protected] |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
January 2021 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||||||||
| Condition Browse | |||||||||||
| Number Of Arms | 1 | ||||||||||
| Arm Group |
Label: Supportive care (levorphanol, opioid regimen) Type: Experimental Description: Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine sulfate, hydromorphone hydrochloride, oxycodone, and oxymorphone hydrochloride for breakthrough pain. |
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| Study Design Info |
Allocation: N/A Intervention Model: Single Group Assignment Primary Purpose: Supportive Care Masking: None (Open Label) |
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