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A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine

Gemcitabine will be administered as an intravenous drip over 30 minutes at a dose of 1000
mg/m2 on days 1, 8, and 15 of each cycle followed by a 7-day treatment rest period. No
treatment will be administered on the 4th week of the cycle. Each cycle is 28 days long.

Sodium bicarbonate is commercially available and supplied as tablets and water soluble
powder. It is stable in solid form and does not need refrigeration. The sodium bicarbonate
will be dispensed by the pharmacy in packets containing 1/3 the daily dose. The patient will
be asked to dissolve the powder in water 3 times per day and consume the dose over a period
of about 30 minutes.

Patients will be required to refrain from use of additional buffering agents (antacids)
including sodium bicarbonate, CaCO3, and aluminum hydroxide.

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the safety and tolerability of oral sodium bicarbonate in patients with advanced pancreatic carcinoma treated with gemcitabine

Outcome Time Frame:

Average of 6 months

Safety Issue:


Principal Investigator

Gregory Springett, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

June 2011

Related Keywords:

  • Pancreatic Cancer
  • pancreas
  • adenocarcinoma
  • metastatic
  • unresectable
  • Carcinoma
  • Pancreatic Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612