A phase I dose-escalation trial of 2-deoxy-d-glucose alone or combined with docetaxel in patients with advanced solid tumors
Purpose This phase I trial was initiated to evaluate the safety, pharmacokinetics (PK) and maximum tolerated dose (MTD) of the glycolytic inhibitor, 2-deoxy- d -glucose (2DG) in combination with docetaxel, in patients with advanced solid tumors. Methods A modified accelerated titration design was us...
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| Veröffentlicht in: | Cancer chemotherapy and pharmacology Jg. 71; H. 2; S. 523 - 530 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
Berlin/Heidelberg
Springer-Verlag
01.02.2013
Springer Springer Nature B.V |
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| ISSN: | 0344-5704, 1432-0843, 1432-0843 |
| Online-Zugang: | Volltext |
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| Abstract | Purpose
This phase I trial was initiated to evaluate the safety, pharmacokinetics (PK) and maximum tolerated dose (MTD) of the glycolytic inhibitor, 2-deoxy-
d
-glucose (2DG) in combination with docetaxel, in patients with advanced solid tumors.
Methods
A modified accelerated titration design was used. 2DG was administered orally once daily for 7 days every other week starting at a dose of 2 mg/kg and docetaxel was administered intravenously at 30 mg/m
2
for 3 of every 4 weeks beginning on day 1 of week 2. Following the completion of dose escalation, cohorts of patients were then treated with 2DG for 21 days or every day of each 4-week cycle for up to 12 cycles.
Results
Thirty-four patients were enrolled: 21 on every other week, 6 on a 21 of 28-day cycle and 7 on the continuous 2DG dosing schedule. There were no dose-limiting toxicities which met the MTD criteria. The most common adverse events were fatigue, sweating, dizziness and nausea mimicking the hypoglycemic symptoms expected from 2DG administration. Therefore, 63 mg/kg was selected as the clinically tolerable dose. The most significant adverse effects noted at 63–88 mg/kg doses were reversible hyperglycemia (100 %), gastrointestinal bleeding (6 %) and reversible grade 3 QTc prolongation (22 %). Eleven patients (32 %) had stable disease, 1 patient (3 %) partial response and 22 patients (66 %) progressive disease as their best response. There was no PK interaction between 2DG and docetaxel.
Conclusion
The recommended dose of 2DG in combination with weekly docetaxel is 63 mg/kg/day with tolerable adverse effects. |
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| AbstractList | This phase I trial was initiated to evaluate the safety, pharmacokinetics (PK) and maximum tolerated dose (MTD) of the glycolytic inhibitor, 2-deoxy-D-glucose (2DG) in combination with docetaxel, in patients with advanced solid tumors.
A modified accelerated titration design was used. 2DG was administered orally once daily for 7 days every other week starting at a dose of 2 mg/kg and docetaxel was administered intravenously at 30 mg/m(2) for 3 of every 4 weeks beginning on day 1 of week 2. Following the completion of dose escalation, cohorts of patients were then treated with 2DG for 21 days or every day of each 4-week cycle for up to 12 cycles.
Thirty-four patients were enrolled: 21 on every other week, 6 on a 21 of 28-day cycle and 7 on the continuous 2DG dosing schedule. There were no dose-limiting toxicities which met the MTD criteria. The most common adverse events were fatigue, sweating, dizziness and nausea mimicking the hypoglycemic symptoms expected from 2DG administration. Therefore, 63 mg/kg was selected as the clinically tolerable dose. The most significant adverse effects noted at 63-88 mg/kg doses were reversible hyperglycemia (100 %), gastrointestinal bleeding (6 %) and reversible grade 3 QTc prolongation (22 %). Eleven patients (32 %) had stable disease, 1 patient (3 %) partial response and 22 patients (66 %) progressive disease as their best response. There was no PK interaction between 2DG and docetaxel.
The recommended dose of 2DG in combination with weekly docetaxel is 63 mg/kg/day with tolerable adverse effects. This phase I trial was initiated to evaluate the safety, pharmacokinetics (PK) and maximum tolerated dose (MTD) of the glycolytic inhibitor, 2-deoxy-d-glucose (2DG) in combination with docetaxel, in patients with advanced solid tumors. A modified accelerated titration design was used. 2DG was administered orally once daily for 7 days every other week starting at a dose of 2 mg/kg and docetaxel was administered intravenously at 30 mg/m^sup 2^ for 3 of every 4 weeks beginning on day 1 of week 2. Following the completion of dose escalation, cohorts of patients were then treated with 2DG for 21 days or every day of each 4-week cycle for up to 12 cycles. Thirty-four patients were enrolled: 21 on every other week, 6 on a 21 of 28-day cycle and 7 on the continuous 2DG dosing schedule. There were no dose-limiting toxicities which met the MTD criteria. The most common adverse events were fatigue, sweating, dizziness and nausea mimicking the hypoglycemic symptoms expected from 2DG administration. Therefore, 63 mg/kg was selected as the clinically tolerable dose. The most significant adverse effects noted at 63-88 mg/kg doses were reversible hyperglycemia (100 %), gastrointestinal bleeding (6 %) and reversible grade 3 QTc prolongation (22 %). Eleven patients (32 %) had stable disease, 1 patient (3 %) partial response and 22 patients (66 %) progressive disease as their best response. There was no PK interaction between 2DG and docetaxel. The recommended dose of 2DG in combination with weekly docetaxel is 63 mg/kg/day with tolerable adverse effects.[PUBLICATION ABSTRACT] This phase I trial was initiated to evaluate the safety, pharmacokinetics (PK) and maximum tolerated dose (MTD) of the glycolytic inhibitor, 2-deoxy-D-glucose (2DG) in combination with docetaxel, in patients with advanced solid tumors.PURPOSEThis phase I trial was initiated to evaluate the safety, pharmacokinetics (PK) and maximum tolerated dose (MTD) of the glycolytic inhibitor, 2-deoxy-D-glucose (2DG) in combination with docetaxel, in patients with advanced solid tumors.A modified accelerated titration design was used. 2DG was administered orally once daily for 7 days every other week starting at a dose of 2 mg/kg and docetaxel was administered intravenously at 30 mg/m(2) for 3 of every 4 weeks beginning on day 1 of week 2. Following the completion of dose escalation, cohorts of patients were then treated with 2DG for 21 days or every day of each 4-week cycle for up to 12 cycles.METHODSA modified accelerated titration design was used. 2DG was administered orally once daily for 7 days every other week starting at a dose of 2 mg/kg and docetaxel was administered intravenously at 30 mg/m(2) for 3 of every 4 weeks beginning on day 1 of week 2. Following the completion of dose escalation, cohorts of patients were then treated with 2DG for 21 days or every day of each 4-week cycle for up to 12 cycles.Thirty-four patients were enrolled: 21 on every other week, 6 on a 21 of 28-day cycle and 7 on the continuous 2DG dosing schedule. There were no dose-limiting toxicities which met the MTD criteria. The most common adverse events were fatigue, sweating, dizziness and nausea mimicking the hypoglycemic symptoms expected from 2DG administration. Therefore, 63 mg/kg was selected as the clinically tolerable dose. The most significant adverse effects noted at 63-88 mg/kg doses were reversible hyperglycemia (100 %), gastrointestinal bleeding (6 %) and reversible grade 3 QTc prolongation (22 %). Eleven patients (32 %) had stable disease, 1 patient (3 %) partial response and 22 patients (66 %) progressive disease as their best response. There was no PK interaction between 2DG and docetaxel.RESULTSThirty-four patients were enrolled: 21 on every other week, 6 on a 21 of 28-day cycle and 7 on the continuous 2DG dosing schedule. There were no dose-limiting toxicities which met the MTD criteria. The most common adverse events were fatigue, sweating, dizziness and nausea mimicking the hypoglycemic symptoms expected from 2DG administration. Therefore, 63 mg/kg was selected as the clinically tolerable dose. The most significant adverse effects noted at 63-88 mg/kg doses were reversible hyperglycemia (100 %), gastrointestinal bleeding (6 %) and reversible grade 3 QTc prolongation (22 %). Eleven patients (32 %) had stable disease, 1 patient (3 %) partial response and 22 patients (66 %) progressive disease as their best response. There was no PK interaction between 2DG and docetaxel.The recommended dose of 2DG in combination with weekly docetaxel is 63 mg/kg/day with tolerable adverse effects.CONCLUSIONThe recommended dose of 2DG in combination with weekly docetaxel is 63 mg/kg/day with tolerable adverse effects. Purpose This phase I trial was initiated to evaluate the safety, pharmacokinetics (PK) and maximum tolerated dose (MTD) of the glycolytic inhibitor, 2-deoxy- d -glucose (2DG) in combination with docetaxel, in patients with advanced solid tumors. Methods A modified accelerated titration design was used. 2DG was administered orally once daily for 7 days every other week starting at a dose of 2 mg/kg and docetaxel was administered intravenously at 30 mg/m 2 for 3 of every 4 weeks beginning on day 1 of week 2. Following the completion of dose escalation, cohorts of patients were then treated with 2DG for 21 days or every day of each 4-week cycle for up to 12 cycles. Results Thirty-four patients were enrolled: 21 on every other week, 6 on a 21 of 28-day cycle and 7 on the continuous 2DG dosing schedule. There were no dose-limiting toxicities which met the MTD criteria. The most common adverse events were fatigue, sweating, dizziness and nausea mimicking the hypoglycemic symptoms expected from 2DG administration. Therefore, 63 mg/kg was selected as the clinically tolerable dose. The most significant adverse effects noted at 63–88 mg/kg doses were reversible hyperglycemia (100 %), gastrointestinal bleeding (6 %) and reversible grade 3 QTc prolongation (22 %). Eleven patients (32 %) had stable disease, 1 patient (3 %) partial response and 22 patients (66 %) progressive disease as their best response. There was no PK interaction between 2DG and docetaxel. Conclusion The recommended dose of 2DG in combination with weekly docetaxel is 63 mg/kg/day with tolerable adverse effects. |
| Author | Chiorean, E. Gabriella Tolba, Khaled Kroll, Stewart Stein, Mark N. Langmuir, Virginia K. Rocha Lima, Caio M. Ricart, Alejandro D. Kurtoglu, Metin Raez, Luis E. Jung, Donald T. Lampidis, Theodore J. Schlesselman, James J. Papadopoulos, Kyriakos Rosenblatt, Joseph DiPaola, Robert S. |
| Author_xml | – sequence: 1 givenname: Luis E. surname: Raez fullname: Raez, Luis E. organization: Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine – sequence: 2 givenname: Kyriakos surname: Papadopoulos fullname: Papadopoulos, Kyriakos organization: Institute for Drug Development – sequence: 3 givenname: Alejandro D. surname: Ricart fullname: Ricart, Alejandro D. organization: Institute for Drug Development – sequence: 4 givenname: E. Gabriella surname: Chiorean fullname: Chiorean, E. Gabriella organization: Indiana University Melvin and Bren Simon Cancer Center – sequence: 5 givenname: Robert S. surname: DiPaola fullname: DiPaola, Robert S. organization: UMDNJ-Cancer Institute of New Jersey – sequence: 6 givenname: Mark N. surname: Stein fullname: Stein, Mark N. organization: UMDNJ-Cancer Institute of New Jersey – sequence: 7 givenname: Caio M. surname: Rocha Lima fullname: Rocha Lima, Caio M. organization: Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine – sequence: 8 givenname: James J. surname: Schlesselman fullname: Schlesselman, James J. organization: Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine – sequence: 9 givenname: Khaled surname: Tolba fullname: Tolba, Khaled organization: Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine – sequence: 10 givenname: Virginia K. surname: Langmuir fullname: Langmuir, Virginia K. organization: Threshold Pharmaceuticals – sequence: 11 givenname: Stewart surname: Kroll fullname: Kroll, Stewart organization: Threshold Pharmaceuticals – sequence: 12 givenname: Donald T. surname: Jung fullname: Jung, Donald T. organization: Threshold Pharmaceuticals – sequence: 13 givenname: Metin surname: Kurtoglu fullname: Kurtoglu, Metin organization: Department of Cell Biology (R-124), Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine – sequence: 14 givenname: Joseph surname: Rosenblatt fullname: Rosenblatt, Joseph organization: Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine – sequence: 15 givenname: Theodore J. surname: Lampidis fullname: Lampidis, Theodore J. email: tlampidi@med.miami.edu organization: Department of Cell Biology (R-124), Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27614557$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/23228990$$D View this record in MEDLINE/PubMed |
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| Keywords | Phase I Head and neck cancers Lung cancer Docetaxel Breast cancer 2-Deoxy Glucose Antineoplastic agent Solid tumor Breast disease Dose escalation Bronchopulmonary Increasing dose Taxane derivatives ENT disease Bronchus disease Clinical trial Advanced stage Antimitotic Human Lung disease Respiratory disease Malignant tumor Mammary gland diseases 2-Deoxy-D-Glucose Head and neck cancer Cancer |
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