Clinical trial NCT02078089 (phase 1, status: terminated)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: morphine, oxcarbazepine
SMILES: CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O, NC(=O)N1C2=CC=CC=C2CC(=O)C2=C1C=CC=C2
Reason stopped: 
    poor accrual
  
Eligibility 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