Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain

This is an interventional supportive care trial for Cancer focused on measuring Refractory cancer pain Read More

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