- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06018883
Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer (PTCA199-3)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The Metastatic PAncreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.
Vitamin C, also called ascorbate, is an essential nutrient for the human body. It modulates metabolism, immune reaction, collagen synthesis, and iron absorption. Some studies have shown that high-dose intravenous Vitamin C may be effective against various types of cancer. Meanwhile, medium or low dose of Vitamin C may enhance the tolerability of chemotherapy by increasing iron absorption, improving anemia, alleviating pain and hand/foot numbness, and thus improving quality of life for patients with pancreatic cancer.
The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy. One hundred patients will be randomly assigned to the experimental group (gemcitabine combined with nab-paclitaxel, Vitamin C) or the control group (gemcitabine combined with nab-paclitaxel). Rate of anemia, rate of hand/foot numbness, severity of pain, quality of life, and overall survival are measured every four weeks.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Ying Yang, MD
- Phone Number: 1307 86 21 64175590
- Email: yangying@fudanpci.org
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Shanghai Cancer Center
-
Contact:
- Ying Yang, MD
- Phone Number: 1307 86 21 64175590
- Email: yangying@fudanpci.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years and ≤ 80 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
- Adequate organ performance based on laboratory blood tests.
- Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- Hemoglobin (Hgb) ≥ 8 g/dL.
- The expected survival ≥ 3 months.
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion Criteria:
- Patients who have received any form of anti-tumor therapy.
- The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- Pregnant or nursing women.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc).
- Renal insufficiency or dialysis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study.
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
- Patients who are unwilling or unable to comply with study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ascorbate
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
Vitamin C 900 mg/day, three times a day, orally.
|
Vitamin C 900 mg/day, three times a day, orally.
Other Names:
Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks
Other Names:
Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
Other Names:
|
Other: Control
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
|
Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks
Other Names:
Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of anemia
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
Rate of anemia after every cycle of chemotherapy
|
At the end of Cycle 1 (each cycle is 28 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life (QOL)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
|
At the end of Cycle 1 (each cycle is 28 days)
|
Overall survival (OS)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
|
At the end of Cycle 1 (each cycle is 28 days)
|
Change of numeric rating scale (NRS)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
Change of NRS and the administration of analgesic drugs after every cycle of chemotherapy.
The range of NRS scale is 0-10 and higher scores mean a worse outcome.
|
At the end of Cycle 1 (each cycle is 28 days)
|
Rate of grade 3 neuropathy
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
Rate of grade 3 neuropathy after every cycle of chemotherapy
|
At the end of Cycle 1 (each cycle is 28 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guopei Luo, MD, Fudan University
Publications and helpful links
General Publications
- Magri A, Germano G, Lorenzato A, Lamba S, Chila R, Montone M, Amodio V, Ceruti T, Sassi F, Arena S, Abrignani S, D'Incalci M, Zucchetti M, Di Nicolantonio F, Bardelli A. High-dose vitamin C enhances cancer immunotherapy. Sci Transl Med. 2020 Feb 26;12(532):eaay8707. doi: 10.1126/scitranslmed.aay8707.
- Drisko JA, Serrano OK, Spruce LR, Chen Q, Levine M. Treatment of pancreatic cancer with intravenous vitamin C: a case report. Anticancer Drugs. 2018 Apr;29(4):373-379. doi: 10.1097/CAD.0000000000000603.
- Cieslak JA, Cullen JJ. Treatment of Pancreatic Cancer with Pharmacological Ascorbate. Curr Pharm Biotechnol. 2015;16(9):759-70. doi: 10.2174/138920101609150715135921.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTCA199-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Pancreatic Adenocarcinoma
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
Georgetown UniversityNational Cancer Institute (NCI); Mayo Clinic; Emory University; Indiana University and other collaboratorsTerminatedMetastatic Colorectal Cancer | Pancreatic Adenocarcinoma | Colorectal Adenocarcinoma | Metastatic Pancreatic CancerUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Metastatic Pancreatic Ductal AdenocarcinomaUnited States
-
Georgetown UniversityERYtech PharmaActive, not recruitingMetastatic Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Ductal Adenocarcinoma | Metastatic Pancreatic Cancer | Metastatic Pancreatic Ductal Adenocarcinoma | Primary Pancreatic Ductal AdenocarcinomaUnited States
-
Translational Genomics Research InstituteMerck Sharp & Dohme LLC; Stand Up To CancerCompletedPancreatic Cancer | Pancreas Adenocarcinoma | Metastatic Pancreatic Adenocarcinoma | Metastatic Pancreatic Cancer | Advanced Pancreatic CancerUnited States
-
Scandion Oncology A/SAlcedis GmbHRecruitingMetastatic Pancreatic Adenocarcinoma | Locally Advanced Pancreatic Adenocarcinoma | Inoperable Disease | Localized Pancreatic AdenocarcinomaDenmark, Germany
-
Mayo ClinicNovoCure Ltd.RecruitingPancreatic Adenocarcinoma | Pancreas Cancer | Metastatic Pancreatic Cancer | Metastatic AdenocarcinomaUnited States
-
Colin D. Weekes, M.D., PhDActuate Therapeutics Inc.; Lustgarten FoundationRecruitingPancreatic Adenocarcinoma | Pancreatic Adenocarcinoma MetastaticUnited States
-
Jean-Luc Van LaethemCelgene CorporationCompletedPancreatic Adenocarcinoma Resectable | Pancreatic Adenocarcinoma Metastatic | Pancreatic Adenocarcinoma Locally AdvancedBelgium
Clinical Trials on Ascorbate
-
Mohammed Milhem, MBBSUniversity of IowaRecruitingSarcoma | Soft Tissue Sarcoma | Bone Sarcoma | Metastatic Bone Tumor | Unresectable Soft Tissue SarcomaUnited States
-
IRCCS San RaffaeleCompletedCoronary Artery Disease | Type II Diabetes Mellitus
-
Sheba Medical CenterRecruitingNewly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor SurgicallyIsrael
-
Fudan UniversityRecruitingMetastatic Pancreatic Cancer | Terminal CancerChina
-
Mohammed MilhemUniversity of IowaActive, not recruitingSoft Tissue SarcomaUnited States
-
Chris Lascola, MDDuke UniversityWithdrawn
-
Azienda USL ModenaCompleted
-
Muhammad FurqanRecruitingNon-small Cell Lung CancerUnited States
-
NBTY, Inc.KGK Science Inc.; Moyad, Mark MD MPHCompleted
-
Mohammed Milhem, MBBSUniversity of Iowa; University of Iowa Adolescent and Young Adult (AYA) Cancer... and other collaboratorsTerminatedSarcoma | Soft Tissue Sarcoma | Bone Sarcoma | Metastatic Bone Tumor | Unresectable Soft Tissue SarcomaUnited States