Gem-TABS in Unresectable Pancreatic Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Reliable Cancer Therapies
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01198821
First received: September 9, 2010
Last updated: November 21, 2013
Last verified: August 2011
  Purpose

The purpose of this study is to:

Find out the largest dose of sodium bicarbonate that can be given with gemcitabine.

Determine if the combination of sodium bicarbonate and gemcitabine produces better control of pancreatic cancer than gemcitabine alone.


Condition Intervention Phase
Pancreatic Cancer
Drug: Sodium bicarbonate (g/kg/day)
Drug: Gemcitabine (mg/m²)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Establish the safety and tolerability of oral sodium bicarbonate in patients with advanced pancreatic carcinoma treated with gemcitabine [ Time Frame: Average of 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine if oral bicarbonate improves overall survival, progression free-survival and response rate in patients with advanced pancreatic cancer [ Time Frame: Average of 6 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral sodium bicarbonate and Gemcitabine Drug: Sodium bicarbonate (g/kg/day)
Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0
Drug: Gemcitabine (mg/m²)
Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000
Other Names:
  • 2',2'-difluorodeoxycytidine
  • Gem-TABS
  • Gemzar®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198821

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Reliable Cancer Therapies
Investigators
Principal Investigator: Gregory Springett, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01198821     History of Changes
Other Study ID Numbers: MCC-16123
Study First Received: September 9, 2010
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
pancreas
adenocarcinoma
metastatic
unresectable

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014