Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial

Background Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical trial was performed to establish safety and tolerability of pharmacological ascorbate combined with gemcitabine in patients with...

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Published inCancer chemotherapy and pharmacology Vol. 71; no. 3; pp. 765 - 775
Main Authors Welsh, J. L., Wagner, B. A., van’t Erve, T. J., Zehr, P. S., Berg, D. J., Halfdanarson, T. R., Yee, N. S., Bodeker, K. L., Du, J., Roberts, L. J., Drisko, J., Levine, M., Buettner, G. R., Cullen, J. J.
Format Journal Article
LanguageEnglish
Published Berlin/Heidelberg Springer-Verlag 01.03.2013
Springer
Springer Nature B.V
Subjects
Adenocarcinoma - drug therapy
Aged
Antimetabolites, Antineoplastic - administration & dosage
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Antioxidants - administration & dosage
Ascorbic Acid - administration & dosage
Ascorbic Acid - blood
Biological and medical sciences
Cancer Research
Chromatography, High Pressure Liquid
Deoxycytidine - administration & dosage
Deoxycytidine - analogs & derivatives
Disease-Free Survival
Drug Administration Schedule
Female
Gastroenterology. Liver. Pancreas. Abdomen
Glutathione - blood
Humans
Infusions, Intravenous
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
Oncology
Original Article
Pancreatic cancer
Pancreatic Neoplasms - drug therapy
Patient Compliance
Patient Safety
Pharmacology. Drug treatments
Pharmacology/Toxicology
Sentinel Lymph Node Biopsy
Tumors
Clinical trial
Ascorbic acid
Phase 1
Pancreatic neoplasm
Gemcitabine
Drug toxicity
Antineoplastic agent
Human
Drug
Toxicity
Vitamin
Malignant tumor
Metastasis
Antimetabolic
Pancreas cancer
Phase I trial
Pyrimidine derivatives
Digestive diseases
Advanced stage
Fluorine Organic compounds
Pharmacokinetics
Pyrimidine nucleoside
Cancer
Pancreatic disease
Online AccessGet full text

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Abstract Background Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical trial was performed to establish safety and tolerability of pharmacological ascorbate combined with gemcitabine in patients with biopsy-proven stage IV pancreatic adenocarcinoma. Design Nine subjects received twice-weekly intravenous ascorbate (15–125 g) employing Simon’s accelerated titration design to achieve a targeted post-infusion plasma level of ≥350 mg/dL (≥20 mM). Subjects received concurrent gemcitabine. Disease burden, weight, performance status, hematologic and metabolic laboratories, time to progression and overall survival were monitored. Results Mean plasma ascorbate trough levels were significantly higher than baseline (1.46 ± 0.02 vs. 0.78 ± 0.09 mg/dL, i.e., 83 vs. 44 μM, p  < 0.001). Adverse events attributable to the drug combination were rare and included diarrhea ( n  = 4) and dry mouth ( n  = 6). Dose-limiting criteria were not met for this study. Mean survival of subjects completing at least two cycles (8 weeks) of therapy was 13 ± 2 months. Conclusions Data suggest pharmacologic ascorbate administered concurrently with gemcitabine is well tolerated. Initial data from this small sampling suggest some efficacy. Further studies powered to determine efficacy should be conducted.
AbstractList Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical trial was performed to establish safety and tolerability of pharmacological ascorbate combined with gemcitabine in patients with biopsy-proven stage IV pancreatic adenocarcinoma. Nine subjects received twice-weekly intravenous ascorbate (15-125 g) employing Simon's accelerated titration design to achieve a targeted post-infusion plasma level of >=350 mg/dL (>=20 mM). Subjects received concurrent gemcitabine. Disease burden, weight, performance status, hematologic and metabolic laboratories, time to progression and overall survival were monitored. Mean plasma ascorbate trough levels were significantly higher than baseline (1.46 ± 0.02 vs. 0.78 ± 0.09 mg/dL, i.e., 83 vs. 44 μM, p < 0.001). Adverse events attributable to the drug combination were rare and included diarrhea (n = 4) and dry mouth (n = 6). Dose-limiting criteria were not met for this study. Mean survival of subjects completing at least two cycles (8 weeks) of therapy was 13 ± 2 months. Data suggest pharmacologic ascorbate administered concurrently with gemcitabine is well tolerated. Initial data from this small sampling suggest some efficacy. Further studies powered to determine efficacy should be conducted.[PUBLICATION ABSTRACT]
Background Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical trial was performed to establish safety and tolerability of pharmacological ascorbate combined with gemcitabine in patients with biopsy-proven stage IV pancreatic adenocarcinoma. Design Nine subjects received twice-weekly intravenous ascorbate (15–125 g) employing Simon’s accelerated titration design to achieve a targeted post-infusion plasma level of ≥350 mg/dL (≥20 mM). Subjects received concurrent gemcitabine. Disease burden, weight, performance status, hematologic and metabolic laboratories, time to progression and overall survival were monitored. Results Mean plasma ascorbate trough levels were significantly higher than baseline (1.46 ± 0.02 vs. 0.78 ± 0.09 mg/dL, i.e., 83 vs. 44 μM, p  < 0.001). Adverse events attributable to the drug combination were rare and included diarrhea ( n  = 4) and dry mouth ( n  = 6). Dose-limiting criteria were not met for this study. Mean survival of subjects completing at least two cycles (8 weeks) of therapy was 13 ± 2 months. Conclusions Data suggest pharmacologic ascorbate administered concurrently with gemcitabine is well tolerated. Initial data from this small sampling suggest some efficacy. Further studies powered to determine efficacy should be conducted.
Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical trial was performed to establish safety and tolerability of pharmacological ascorbate combined with gemcitabine in patients with biopsy-proven stage IV pancreatic adenocarcinoma.BACKGROUNDTreatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical trial was performed to establish safety and tolerability of pharmacological ascorbate combined with gemcitabine in patients with biopsy-proven stage IV pancreatic adenocarcinoma.Nine subjects received twice-weekly intravenous ascorbate (15-125 g) employing Simon's accelerated titration design to achieve a targeted post-infusion plasma level of ≥350 mg/dL (≥20 mM). Subjects received concurrent gemcitabine. Disease burden, weight, performance status, hematologic and metabolic laboratories, time to progression and overall survival were monitored.DESIGNNine subjects received twice-weekly intravenous ascorbate (15-125 g) employing Simon's accelerated titration design to achieve a targeted post-infusion plasma level of ≥350 mg/dL (≥20 mM). Subjects received concurrent gemcitabine. Disease burden, weight, performance status, hematologic and metabolic laboratories, time to progression and overall survival were monitored.Mean plasma ascorbate trough levels were significantly higher than baseline (1.46 ± 0.02 vs. 0.78 ± 0.09 mg/dL, i.e., 83 vs. 44 μM, p < 0.001). Adverse events attributable to the drug combination were rare and included diarrhea (n = 4) and dry mouth (n = 6). Dose-limiting criteria were not met for this study. Mean survival of subjects completing at least two cycles (8 weeks) of therapy was 13 ± 2 months.RESULTSMean plasma ascorbate trough levels were significantly higher than baseline (1.46 ± 0.02 vs. 0.78 ± 0.09 mg/dL, i.e., 83 vs. 44 μM, p < 0.001). Adverse events attributable to the drug combination were rare and included diarrhea (n = 4) and dry mouth (n = 6). Dose-limiting criteria were not met for this study. Mean survival of subjects completing at least two cycles (8 weeks) of therapy was 13 ± 2 months.Data suggest pharmacologic ascorbate administered concurrently with gemcitabine is well tolerated. Initial data from this small sampling suggest some efficacy. Further studies powered to determine efficacy should be conducted.CONCLUSIONSData suggest pharmacologic ascorbate administered concurrently with gemcitabine is well tolerated. Initial data from this small sampling suggest some efficacy. Further studies powered to determine efficacy should be conducted.
Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical trial was performed to establish safety and tolerability of pharmacological ascorbate combined with gemcitabine in patients with biopsy-proven stage IV pancreatic adenocarcinoma. Nine subjects received twice-weekly intravenous ascorbate (15-125 g) employing Simon's accelerated titration design to achieve a targeted post-infusion plasma level of ≥350 mg/dL (≥20 mM). Subjects received concurrent gemcitabine. Disease burden, weight, performance status, hematologic and metabolic laboratories, time to progression and overall survival were monitored. Mean plasma ascorbate trough levels were significantly higher than baseline (1.46 ± 0.02 vs. 0.78 ± 0.09 mg/dL, i.e., 83 vs. 44 μM, p < 0.001). Adverse events attributable to the drug combination were rare and included diarrhea (n = 4) and dry mouth (n = 6). Dose-limiting criteria were not met for this study. Mean survival of subjects completing at least two cycles (8 weeks) of therapy was 13 ± 2 months. Data suggest pharmacologic ascorbate administered concurrently with gemcitabine is well tolerated. Initial data from this small sampling suggest some efficacy. Further studies powered to determine efficacy should be conducted.
Author Yee, N. S.
Du, J.
Levine, M.
Buettner, G. R.
Zehr, P. S.
Berg, D. J.
Halfdanarson, T. R.
Welsh, J. L.
Roberts, L. J.
Bodeker, K. L.
Cullen, J. J.
Wagner, B. A.
van’t Erve, T. J.
Drisko, J.
AuthorAffiliation 5 Penn State Hershey Cancer Institute, Hersey, Pennsylvania, USA
9 The Veterans’ Affairs Medical Center, Iowa City, Iowa, USA
3 The Holden Comprehensive Cancer Center, The University of Iowa, Iowa City, Iowa, USA
2 Department of Radiation Oncology, The University of Iowa Carver College of Medicine, Iowa City, Iowa, USA
4 Department of Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, Iowa, USA
6 Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, Tennessee, USA
7 Integrative Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA
8 Molecular and Clinical Nutrition Section, Digestive Diseases Branch, National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA
1 Department of Surgery, The University of Iowa Carver College of Medicine, Iowa City, Iowa, USA
AuthorAffiliation_xml – name: 1 Department of Surgery, The University of Iowa Carver College of Medicine, Iowa City, Iowa, USA
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– name: 6 Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, Tennessee, USA
– name: 4 Department of Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, Iowa, USA
– name: 8 Molecular and Clinical Nutrition Section, Digestive Diseases Branch, National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA
– name: 7 Integrative Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA
– name: 5 Penn State Hershey Cancer Institute, Hersey, Pennsylvania, USA
– name: 9 The Veterans’ Affairs Medical Center, Iowa City, Iowa, USA
– name: 3 The Holden Comprehensive Cancer Center, The University of Iowa, Iowa City, Iowa, USA
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BackLink http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27610400$$DView record in Pascal Francis
https://www.ncbi.nlm.nih.gov/pubmed/23381814$$D View this record in MEDLINE/PubMed
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Issue 3
Keywords Clinical trial
Ascorbic acid
Phase 1
Pancreatic neoplasm
Gemcitabine
Drug toxicity
Antineoplastic agent
Human
Drug
Toxicity
Vitamin
Malignant tumor
Metastasis
Antimetabolic
Pancreas cancer
Phase I trial
Pyrimidine derivatives
Digestive diseases
Advanced stage
Fluorine Organic compounds
Pharmacokinetics
Pyrimidine nucleoside
Cancer
Pancreatic disease
Language English
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Snippet Background Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase...
Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical...
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pubmed
pascalfrancis
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springer
SourceType Open Access Repository
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Publisher
StartPage 765
SubjectTerms Adenocarcinoma - drug therapy
Aged
Antimetabolites, Antineoplastic - administration & dosage
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Antioxidants - administration & dosage
Ascorbic Acid - administration & dosage
Ascorbic Acid - blood
Biological and medical sciences
Cancer Research
Chromatography, High Pressure Liquid
Deoxycytidine - administration & dosage
Deoxycytidine - analogs & derivatives
Disease-Free Survival
Drug Administration Schedule
Female
Gastroenterology. Liver. Pancreas. Abdomen
Glutathione - blood
Humans
Infusions, Intravenous
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
Oncology
Original Article
Pancreatic cancer
Pancreatic Neoplasms - drug therapy
Patient Compliance
Patient Safety
Pharmacology. Drug treatments
Pharmacology/Toxicology
Sentinel Lymph Node Biopsy
Tumors
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Title Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial
URI https://link.springer.com/article/10.1007/s00280-013-2070-8
https://www.ncbi.nlm.nih.gov/pubmed/23381814
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https://pubmed.ncbi.nlm.nih.gov/PMC3587047
Volume 71
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