- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01654861
Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)
July 24, 2018 updated by: Eastern Regional Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19124
- Eastern Regional Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HDIVC
Gemcitabine (Gemzar), 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Weekly for up to 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-Tumor Response
Time Frame: Every 2 months for up to 6 months.
|
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).
|
Every 2 months for up to 6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eiko Klimant, MD, FACP, Eastern Regional Medical Center
- Principal Investigator: Heather Wright, ND, FABNO, Eastern Regional Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 13, 2012
First Submitted That Met QC Criteria
July 30, 2012
First Posted (Estimate)
August 1, 2012
Study Record Updates
Last Update Posted (Actual)
July 26, 2018
Last Update Submitted That Met QC Criteria
July 24, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Gemcitabine
- Ascorbic Acid
Other Study ID Numbers
- ERMC 11-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Adenocarcinoma of the Pancreas
-
Samyang Biopharmaceuticals CorporationUnknownMetastatic Adenocarcinoma of the Pancreas | Recurrent Adenocarcinoma of the PancreasKorea, Republic of
-
Institut de Recherches Internationales ServierNot yet recruitingMetastatic Adenocarcinoma of the PancreasJapan
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Bristol-Myers Squibb; Stand Up To Cancer; Aduro Biotech, Inc.; American Association... and other collaboratorsCompletedPreviously Treated Metastatic Adenocarcinoma of the PancreasUnited States
-
Centre Leon BerardMerck Sharp & Dohme LLC; Debiopharm International SACompletedAdenocarcinoma of the Pancreas | Adenocarcinoma of the Rectum | Adenocarcinoma of the ColonFrance
-
Kyowa Hakko Kirin Pharma, Inc.Teva PharmaCompletedAdenocarcinoma of the Pancreas | Solid Tumour | Adenocarcinoma of the Colorectal
-
Minneamrita Therapeutics LLCRecruitingMetastatic Adenocarcinoma of the PancreasKorea, Republic of
-
IpsenActive, not recruitingMetastatic Adenocarcinoma of the PancreasUnited States, Spain, Hungary, France, Portugal, Korea, Republic of, Germany, United Kingdom, Austria, Italy, Israel, Australia, Brazil, Czechia, Belgium, Russian Federation, Canada, Greece
-
Grupo Gallego de Investigaciones OncologicasCompletedMetastatic Adenocarcinoma of the PancreasSpain
-
NantCell, Inc.TakedaTerminatedCancer | Pancreatic Cancer | Advanced Solid Tumors | Metastatic Cancer | Bone Metastases | Solid Tumors | Pancreas Cancer | Adenocarcinoma of the Pancreas | Oncology | Cancer of Pancreas | Metastatic Pancreatic Cancer | Metastases | Cancer of the Pancreas | Advanced Malignancy | Oncology Patients | Endocrine CancerItaly, Spain, United Kingdom, Belgium, Canada, Denmark, Romania, United States, Germany, Netherlands, Korea, Republic of, Russian Federation, Australia, Austria, Lithuania, Portugal, Greece, Poland, Switzerland, Serbia, Bulgaria, ... and more
-
University of Michigan Rogel Cancer CenterCompletedAdenocarcinoma of the PancreasUnited States
Clinical Trials on Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)
-
Virginia Commonwealth UniversityCompletedMyeloid Leukemia | Myelodysplasia | Lymphoid Leukemia | Monocytic LeukemiaUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...TerminatedNon-Hodgkin LymphomaUnited States
-
Shahid Beheshti UniversityCompletedAbdominal HysterectomyIran, Islamic Republic of
-
Copenhagen University Hospital at HerlevRigshospitalet, Denmark; University of CopenhagenCompleted
-
Peking University First HospitalCompletedInflammation | UremiaChina
-
United States Army Institute of Surgical ResearchUniversity of MiamiWithdrawn
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedCharcot-Marie-Tooth Disease | Hereditary Motor and Sensory NeuropathiesNetherlands
-
In-Young Choi, Ph.D.CompletedType 2 Diabetes | Oxidative StressUnited States
-
Hunter Holmes Mcguire Veteran Affairs Medical CenterMcGuire Research InstituteCompletedCOVID-19 | HypoxiaUnited States
-
Stichting Achmea Slachtoffer en SamenlevingCompletedRSD (Reflex Sympathetic Dystrophy) | Algodystrophy | CRPS Type INetherlands