Gem-TABS in Unresectable Pancreatic Carcinoma

Exclusion Criteria

• •Patients who have had prior chemotherapy for pancreatic adenocarcinoma in the metastatic setting
• •Patients who have received chemoradiation within the last 6 weeks prior to registration
• •Patients with known allergy or severe reactions to gemcitabine
• •Patients with uncontrolled hypertension and history of uncontrolled congestive heart failure
• •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.