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Trial record 12 of 68732 for:    cancer

Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02078089
Recruitment Status : Terminated (Poor Accrual)
First Posted : March 5, 2014
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Costantine Albany, Indiana University

Brief Summary:
This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary endpoints are improving pain control, reduce morphine use and improve the quality of life.

Condition or disease Intervention/treatment Phase
Cancer Drug: Morphine Drug: Oxcarbazepine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase Ib Study of Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain
Actual Study Start Date : March 6, 2014
Actual Primary Completion Date : December 11, 2014
Actual Study Completion Date : December 11, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Oxcarbazepine and Morphine

Patients must be on stable or increasing doses of greater than or equal to 180 mg of morphine sulfate per day. Morphine is taken orally for 42 days.

In addition to Morphine, patients will also receive oral Oxcarbazepine 150 mg, every 12 hours, for 2 weeks, then increase the dose to 300 mg, every 12 hours, for 2 weeks and then increase the dose to 450 mg, every 12 hours, for the final 2 weeks. Patients will take oral tablets of oxcarbazepine for a total of 42 days.

Drug: Morphine
Morphine will be given to patients as part of their standard care
Other Name: Morphine Sulfate

Drug: Oxcarbazepine
Can be taken with or without food at the same time as morphine. Morphine will be provided to patients free of charge.
Other Name: Tileptal




Primary Outcome Measures :
  1. Number of patients with adverse events as a measure of safety and toxicity [ Time Frame: 1 year ]
    Evaluate the safety and toxicity of oxcarbazepine in combination with morphine


Secondary Outcome Measures :
  1. Changes in Pain control [ Time Frame: 1 year ]
    Evaluate changes in pain control after adding oxcarbazepine to morphine

  2. Changes in Consumption [ Time Frame: 1 year ]
    Evaluate changes morphine consumption after adding oxcarbazepine to morphine

  3. Changes in Quality of Life [ Time Frame: 1 year ]
    Evaluate changes in Quality of Life after adding oxcarbazepine to morphine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent and HIPAA authorization for release of personal health information.

    •≥ 18 years old at the time of informed consent

  • Patients with histologically confirmed diagnosis of cancer NOTE: Patients with active cancer or post treatment are allowed on the study.
  • Patients must be receiving stable or increasing doses of morphine for 1-2 weeks prior to registration for protocol therapy.

NOTE: Switching patient from current pain regimen to morphine equivalent for at least 1-2 weeks prior to registration for protocol therapy is required.

  • Requiring greater than or equal to 180 mg of morphine per day. See Appendix 1 for Morphine Conversion Calculator.
  • Inadequately controlled pain even with the use of morphine (VAS score >5) See Appendix 8
  • Rescue pain medications are allowed this may include the use of NSAIDS or Tylenol as well as morphine IR.
  • ECOG Performance Status of 0-2
  • Ability to swallow and tolerate oral tablets.
  • Patients getting radiation therapy are allowed at the discretion of the treating physician.
  • Females of childbearing potential must have a negative pregnancy test NOTE: Females are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (> 12 months since last menses).

NOTE: Females using hormonal contraceptives should be switched to non-hormonal forms of contraception.

The following laboratory values must be obtained. Patient with aplastic anemia will be excluded.

  • White blood cell count (WBC) ≥ 3.0 K/mm3
  • Absolute neutrophil count ≥ 1.5 K/mm3
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Platelets ≥ 75 K/mm3
  • Creatinine ≤ 1.5 mg/dl
  • Bilirubin ≤ 1.5 x ULN
  • Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
  • Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN

Exclusion Criteria:

• Active central nervous system (CNS) metastases. Patients with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician.

NOTE: Patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.

• Concurrent use of adjuvant medication such as but not limited to: gabapentin, pregabalin or duloxetine etc.

NOTE: Patients on gabapentin or pregabalin can be considered if they can be tapered off before enrolling on the study.

  • Treatment with any investigational agent within 30 days prior to registration for protocol therapy.
  • Patient with rapidly escalating pain that require hospitalization or an intravenous opioid therapy
  • Concurrent participation in a clinical trial which involves another investigational agent.
  • Concurrent use of medications that are strong CYP3A4 inhibitors within 14 days prior to registration for protocol therapy as Oxcarbazepine is strong CYP3A4 inducer. See Appendix 7.

NOTE: Concurrent use of other CYP3A4 inhibitors may be allowed at the discretion of the treating physician or principal investigator.

  • Allergic reaction to carbamazepine or oxcarbazepine (HLA-B1502)
  • Allergy or other contraindication to morphine sulphate
  • Opiate-induced uncontrolled constipation or bowel obstruction
  • Patient who lives alone.
  • Female who is pregnant or breastfeeding
  • Patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078089


Locations
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United States, Indiana
Indiana Univeristy Health Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Costantine Albany
Investigators
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Principal Investigator: Costantine Albany, M.D. Indiana University

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Responsible Party: Costantine Albany, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT02078089     History of Changes
Other Study ID Numbers: IUCRO-0453
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Costantine Albany, Indiana University:
Refractory cancer pain

Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Oxcarbazepine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers