Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain

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