Metastatic Adenocarcinoma of the PancreasPhase 1NCT01654861
Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)
A Phase 1 study testing Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C) in people with Metastatic Adenocarcinoma of the Pancreas, run by Eastern Regional Medical Center at 1 site in United States.
Trial summary
The combination of gemcitabine and HDIVC is safe and may favorably change the clinical course for an individual patient. The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in preclinical models, where HDIVC creates a pro-oxidative effect that adds to the anti-tumor effect of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Adenocarcinoma of the Pancreas
- What is being tested?
- Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient ≥ 18 years of age
- Biopsy proven adenocarcinoma of the pancreas
- Evidence of metastatic disease
- Received at least 1 prior chemotherapy treatment regimen with disease progression
- May have had any prior chemotherapy regimen including any gemcitabine based regimen or FOLFIRINOX
- May have participated in a prior study protocol
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- May have had prior treatment with HDIVC
- Anticipated survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status = 0,1, or 2
- The patient must have screening laboratory: ANC ≥ 1,500/mm3, Hemoglobin > 8g/dL, Platelets ≥ 100,000/mm3, Total Bilirubin < 1.5mg/dL, Creatinine ≤ 1.5mg/dL, Transaminases < 2.5 x upper limit of normal, Urine Uric Acid < 1.000 mg/d, Urine pH < 6, Urine microscopic negative for oxalates (if positive, reflex urinary oxalates < 60mg/d), PT INR ≤ 1.5, unless patient is on full dose warfarin
- Glucose-6-phosphate dehydrogenase deficiency (G6PD) normal status via blood test The fluorescent spot test is the simplest, most reliable, and most sensitive of the G6PD screening tests
- Willingness to undergo central line placement and able to manage care of the entry site safely
- Willingness to adhere to supplemental oral dose regimen of ascorbic acid 500mg taken twice daily
- All other nutritional supplements would be discontinued for the duration of the trial except for pancreatic enzymes and probiotics
- Patients must be able to take food orally or have a peg tube for feeding
- Able to give consent for protocol participation
Who cannot join
- Glucose-6-phosphate dehydrogenase deficiency (G6PD)
- Renal insufficiency : serum creatinine of > 1.5 mg /dl or evidence of oxalosis by urinalysis prior to enrollment and prior to each HDIVC infusion
- Documentation or report of history of kidney stones or urinary oxalosis.
- Co-morbid condition that would affect survival: congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars of > 300 mg / dl, patients with known chronic active hepatitis or cirrhosis
- Currently active second malignancy
- Chronic hemodialysis
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- Iron overload/ Hemochromatosis: Ferritin > 500 ng / ml
- Wilson's disease
- Pregnant or lactating female (pre- menopausal females will undergo pregnancy test prior to administration of protocol drugs throughout treatment cycles during this study)
- Aspirin use exceeding 81 mg per day
- Acetaminophen use exceeding 2 g per day
- Known brain metastasis
- Active tobacco smokers
- Treatment with the combination of HDIVC and gemcitabine previously
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
About this study
Official title: Evaluation of the Safety and Efficacy of Standard Dose Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) Treatment for Patients With Metastatic Adenocarcinoma of the Pancreas.
- The combination of gemcitabine and HDIVC is safe and may favorably change the clinical course for an individual patient.
- The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in preclinical models, where HDIVC creates a pro-oxidative effect that adds to the anti-tumor effect of gemcitabine.
- The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).
- The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg infusion may create sustained elevation in Vitamin C plasma levels for increased cytotoxic effect.
- The addition of HDIVC \& oral supplementation of Vitamin C to standard treatment with gemcitabine may improve quality of life for patients with comparison to prior to treatment start of this protocol.
- CA 19-9 and inflammatory markers may show trends for patients in this trial.
- Being tested
- Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)Drug
Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.
| Study group | Role | What they receive |
|---|---|---|
| HDIVC | Experimental | Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C). Receives: Drug: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events as a Measure of Safety and Tolerability
Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.
Measured: Weekly for up to 6 months.
Secondary outcomes (1)
Anti-Tumor Response
CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Every 2 months for up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: recruiting or enrolling participants has halted prematurely and will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eiko Klimant, MD, FACP, Principal investigator, Eastern Regional Medical CenterHeather Wright, ND, FABNO, Principal investigator, Eastern Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654861
- Sponsor's protocol ID
- ERMC 11-11
- Status last verified
- Jan 2018
- First submitted
- 13 Jul 2012
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Standard Dose Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) Treatment for Patients With Metastatic Adenocarcinoma of the Pancreas.
- ClinicalTrials.gov ID
- NCT01654861
- Acronym / sponsor ID
- ERMC 11-11
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting or enrolling participants has halted prematurely and will not resume
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Eastern Regional Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Posted 1 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The combination of gemcitabine and HDIVC is safe and may favorably change the clinical course for an individual patient.
- The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in preclinical models, where HDIVC creates a pro-oxidative effect that adds to the anti-tumor effect of gemcitabine.
- The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).
- The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg infusion may create sustained elevation in Vitamin C plasma levels for increased cytotoxic effect.
- The addition of HDIVC \& oral supplementation of Vitamin C to standard treatment with gemcitabine may improve quality of life for patients with comparison to prior to treatment start of this protocol.
- CA 19-9 and inflammatory markers may show trends for patients in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDIVC | Experimental | Drug: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient ≥ 18 years of age
- Biopsy proven adenocarcinoma of the pancreas
- Evidence of metastatic disease
- Received at least 1 prior chemotherapy treatment regimen with disease progression
- May have had any prior chemotherapy regimen including any gemcitabine based regimen or FOLFIRINOX
Key exclusion criteria (14 listed)
- Glucose-6-phosphate dehydrogenase deficiency (G6PD)
- Renal insufficiency : serum creatinine of > 1.5 mg /dl or evidence of oxalosis by urinalysis prior to enrollment and prior to each HDIVC infusion
- Documentation or report of history of kidney stones or urinary oxalosis.
- Co-morbid condition that would affect survival: congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars of > 300 mg / dl, patients with known chronic active hepatitis or cirrhosis
- Currently active second malignancy
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 |
|---|---|---|
| Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment. | Drug | HDIVC |
Primary outcome
Adverse Events as a Measure of Safety and Tolerability
Time frame: Weekly for up to 6 months.
Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.
1 secondary outcome
Anti-Tumor Response
Time frame: Every 2 months for up to 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eiko Klimant, MD, FACP principal investigator
Eastern Regional Medical Center
Heather Wright, ND, FABNO principal investigator
Eastern Regional Medical Center
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 Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C) in people with Metastatic Adenocarcinoma of the Pancreas, run by Eastern Regional Medical Center 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 16 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Jul 2018. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events as a Measure of Safety and Tolerability (time frame: Weekly for up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.