A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine
- Patients must have histologically confirmed pancreatic adenocarcinoma that is
metastatic or unresectable.
- Patients previously untreated with chemotherapy in the metastatic setting. Prior 5-FU
or capecitabine treatment is allowed if: 1) it was given as part of a combined
modality chemoradiation regimen in the adjuvant setting and; 2) no greater than 30%
of bone marrow was included in the field and; 3) the treatment free interval has been
≥ 6 weeks.
- Patients must have measurable disease, defined as at least one lesion that can be
measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with
conventional techniques or as ≥ 10 mm with spiral CT scan.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥ 3,000/μl
- absolute neutrophil count ≥ 1,500/μl
- platelets ≥ 100,000/μl
- total bilirubin ≤2.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal - or -
- AST(SGOT)/ALT(SGPT) ≤5 X institutional upper limit of normal in patients with
- creatinine ≤1.5 X institutional upper limit of normal and creatinine clearance >
30 ml/min (Cockcroft-Gault method)
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of
therapy (female patients of childbearing potential). Postmenopausal women must have
been amenorrheic for at least 12 months to be considered of non-childbearing
potential. Patients will agree to continue contraception for 30 days from the date of
the last study drug administration.
- Ability to understand and the willingness to sign a written informed consent
- Patients who have had prior chemotherapy for pancreatic adenocarcinoma in the
- Patients who have received chemoradiation within the last 6 weeks prior to
- Patients with known allergy or severe reactions to gemcitabine
- Patients with uncontrolled hypertension and history of uncontrolled congestive heart
- Patients may not be receiving any other investigational agents or received
investigational agents within the 28 days prior to registration.
- Patients with known brain metastases are excluded.
- Patients with active (not in remission) malignancies other than pancreatic cancer
- Pregnant women are excluded from this study because gemcitabine is a Class D agent
with the potential for teratogenic or abortifacient effects.
- Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving
combination antiretroviral therapy are excluded from the study.
- Patients who require ongoing (chronic) treatment with medications, the absorption of
which may be altered by NaHCO3 (benzodiazepines, flecainide, ketoconazole, lithium,
iron salts, methenamine, methotrexate, quinidine, sulfa-containing antibiotics, and
tetracycline), and cannot be switched to alternate medications are excluded.
- Patients who routinely use antacids including sodium bicarbonate, aluminum hydroxide,
and calcium carbonate are excluded.
- Patients with a documented history of severe* COPD are excluded. *defined as GOLD
stage III or greater. For patients with a documented history of COPD, pulmonary
function tests to establish GOLD stage must be documented within 6 weeks prior to
start of protocol therapy.