Gem-TABS in Unresectable Pancreatic Carcinoma

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreas, adenocarcinoma, metastatic, unresectable Read More

Inclusion Criteria:

• 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 liver metastasis
  • 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 document.

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.