Gem-TABS in Unresectable Pancreatic Carcinoma

NCT01198821 | Completed Phase 1 DMC

• 1 other identifier: MCC-16123
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

pancreas; adenocarcinoma; metastatic; unresectable

Outcome Measures

Primary Outcomes (1)

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

  Average of 6 months

Secondary Outcomes (1)

• Determine if oral bicarbonate improves overall survival, progression free-survival and response rate in patients with advanced pancreatic cancer

  Average of 6 months

Study Arms (1)

Oral sodium bicarbonate and Gemcitabine

EXPERIMENTAL

Drug: Sodium bicarbonate (g/kg/day); Drug: Gemcitabine (mg/m²)

Interventions

Sodium bicarbonate (g/kg/day) DRUG

Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0

Oral sodium bicarbonate and Gemcitabine

Gemcitabine (mg/m²) DRUG

Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000

Also known as: 2',2'-difluorodeoxycytidine, Gem-TABS, Gemzar®

Oral sodium bicarbonate and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Reliable Cancer Therapies: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Gillies RJ, Ibrahim-Hashim A, Ordway B, Gatenby RA. Back to basic: Trials and tribulations of alkalizing agents in cancer. Front Oncol. 2022 Nov 14;12:981718. doi: 10.3389/fonc.2022.981718. eCollection 2022.

  PMID: 36452492 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma; Neoplasm Metastasis

Interventions

Sodium Bicarbonate; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gregory Springett, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)