Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation

PRIMARY OBJECTIVES:

I. Collect preliminary data on the safety and efficacy of two analgesic regimens that can be
used to design larger studies for comparing such regimens.

SECONDARY OBJECTIVES:

I. Examine effects of the treatment regimens on pain control, oral mucositis, and
quality-of-life ratings scores during and after chemoradiation therapy (CRT).

TERTIARY OBJECTIVES:

I. To assess treatment regimen effect on patient nutrition and hydration status during and
after CRT (weight loss, vitals, oral [PO] tolerance, etc.).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive gabapentin PO thrice daily (TID) for up to 7 weeks during
radiotherapy.

ARM II: Patients receive gabapentin PO TID, methadone hydrochloride PO twice daily (BID), and
oxycodone hydrochloride PO every 8 hours (Q8H) as needed (PRN) for up to 7 weeks during
radiotherapy.

All patients may continue to receive treatment for pain throughout their course of
chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

After completion of study, patients are followed up at 30 days, and at 3, 6, 9, and 12
months. Patients requiring prolonged analgesic therapy may be followed up every 6 months for
24 months.

Inclusion Criteria:

- Patients who are eligible for chemoradiation therapy of the head and neck

- Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal

- Have a clinical stage II-IV head and neck carcinoma

- Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Ability to swallow and retain oral medication or take through a feeding tube

- Patients of child-bearing potential must agree to use adequate contraceptive methods
(e.g., hormonal or barrier method of birth control; abstinence) prior to study entry;
should a woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately

- Patient or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Patients who have previously been treated with surgery or radiation for head and neck
cancer and/or are being treated for recurrent head and neck cancer

- Patients with known brain metastases will be excluded from this clinical trial

- Any patients prescribed medications for chronic pain and/or neuropathy will be
excluded, including patients under treatment of a pain specialist or substance-abuse
programs

- Uncontrolled concurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant or nursing female patients

- Unwilling or unable to follow protocol requirements

- Any condition which in the Investigator's opinion deems the patient an unsuitable
candidate to receive study drug

- Received an investigational agent within 30 days prior to enrollment

- Patients on medications that prolong QT interval

- Patients on dialysis or with transplanted organs

- Patients already enrolled on other studies of systemic pain control agents