Pancreatic CancerPhase 1NCT01198821
Gem-TABS in Unresectable Pancreatic Carcinoma
A Phase 1 study testing Sodium bicarbonate (g/kg/day) and Gemcitabine (mg/m²) in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Sodium bicarbonate (g/kg/day) and Gemcitabine (mg/m²)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Sodium bicarbonate (g/kg/day), Gemcitabine (mg/m²)
- Keywords
- pancreas, adenocarcinoma, metastatic, unresectable
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate (g/kg/day)Drug
Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0
Gemcitabine (mg/m²)Drug
Also called 2',2'-difluorodeoxycytidine, Gem-TABS, Gemzar®
Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000
| Study group | Role | What they receive |
|---|---|---|
| Oral sodium bicarbonate and Gemcitabine | Experimental | Not described Receives: Drug: Sodium bicarbonate (g/kg/day); Drug: Gemcitabine (mg/m²) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the safety and tolerability of oral sodium bicarbonate in patients with advanced pancreatic carcinoma treated with gemcitabine
Measured: 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
Measured: Average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Reliable Cancer Therapies
- Responsible party
- Sponsor
- Investigators
- Gregory Springett, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198821
- Sponsor's protocol ID
- MCC-16123
- Status last verified
- Feb 2017
- First submitted
- 9 Sep 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36452492
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine
- ClinicalTrials.gov ID
- NCT01198821
- Acronym / sponsor ID
- MCC-16123
- Conditions
- Pancreatic Cancer
- Keywords
- pancreas, adenocarcinoma, metastatic, unresectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Reliable Cancer Therapies
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral sodium bicarbonate and Gemcitabine | Experimental | Drug: Sodium bicarbonate (g/kg/day), Drug: Gemcitabine (mg/m²) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonate (g/kg/day)Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0 | Drug | Oral sodium bicarbonate and Gemcitabine |
| Gemcitabine (mg/m²)Also: 2',2'-difluorodeoxycytidine, Gem-TABS, Gemzar®Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000 | Drug | Oral sodium bicarbonate and Gemcitabine |
Primary outcome
Establish the safety and tolerability of oral sodium bicarbonate in patients with advanced pancreatic carcinoma treated with gemcitabine
Time frame: Average of 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 36452492Gillies 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Springett, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium bicarbonate (g/kg/day) and Gemcitabine (mg/m²) in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the safety and tolerability of oral sodium bicarbonate in patients with advanced pancreatic carcinoma treated with gemcitabine (time frame: Average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01198821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.