Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

Single institution Phase I/II study of sodium bicarbonate in combination with standard
medical management for patients with moderate to severe tumor related pain.

Patients with metastatic solid malignancies and patients with hematologic malignancies with
moderate to severe tumor related pain on a stable opioid regimen will be the subjects of
this study.

Inclusion Criteria:

- Patients must have metastatic or unresectable solid malignancy or hematologic
malignancy (multiple myeloma or lymphoma) and must have moderate to severe tumor
related pain visual assessment scale (VAS)>4) on a stable or no opioid regimen (at
least 3 days of an opiate regimen). VAS score should be greater than 4 at screening
to be eligible.

- No planned palliative surgery, palliative radiotherapy for at least 4 weeks. However
prior radiotherapy, and surgery is allowed and not limited to the number of
procedures and courses. Concomitant chemotherapy with agents indicated in protocol
guidelines (Tables 10 and 11B, Appendix IV) is allowed.

- No evidence of neurologic or psychiatric compromise which in the opinion of the
investigator will interfere with completion of study assessments

- Age greater than 18 years and able to understand and sign the informed consent
document

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status
less than 3.

- A female patient and a male patient's female partner, of childbearing potential, must
agree to use 2 adequate barrier methods of contraception to prevent pregnancy or to
abstain from heterosexual activity throughout the study, starting from Visit 1, while
receiving protocol-specified medication, and for 1 month after stopping the
medication.

Exclusion Criteria:

- Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not
eligible.

- Patients with only chronic non-malignant pain are not eligible.

- Patients with renal insufficiency (creatinine > 2.5mg/dL) are excluded.

- Patients with history of congestive heart failure or pulmonary artery hypertension
will be excluded.

- Patients with uncontrolled hypertension (systolic pressure >160, diastolic pressure
>100) despite maximal antihypertensive therapy

- Patients unable to ingest sodium bicarbonate capsules (such as patients with
dysphagia or severe nausea)

- Patients with ECOG performance status 3 or higher

- Patients with acute leukemia, myelodysplastic syndrome, and chronic myeloid leukemia
are not eligible.

- Pregnant or lactating patients are not eligible.

- Patients with known allergy to sodium bicarbonate or patients with preexisting renal
or acid base disorders for which sodium bicarbonate is contraindicated (such as
metabolic alkalosis, severe congestive heart failure, hypernatremia, and hypocalcemia
(see above))

- Patients with severe ongoing infections which places the patients at increased risks
from therapy in the opinion of the investigator

- Patients receiving concomitant chemotherapy with agents indicated in protocol
guidelines (Tables 10 and 11B, Appendix IV) or target therapy intended to prolong
life within 2 weeks of starting the study drug

- Patients receiving experimental therapy within 2 weeks of starting study treatment