Glufosfamide administered using a 1-hour infusion given as first-line treatment for advanced pancreatic cancer. A phase II trial of the EORTC-new drug development group
dc.contributor.author | Briassoulis, E. Ch | en |
dc.contributor.author | Pavlidis, Nicholas | en |
dc.contributor.author | Terret, C. | en |
dc.contributor.author | Bauer, J. | en |
dc.contributor.author | Fiedler, W. | en |
dc.contributor.author | Schöffski, P. | en |
dc.contributor.author | Raoul, J. L. | en |
dc.contributor.author | Hess, D. | en |
dc.contributor.author | Selvais, R. | en |
dc.contributor.author | Lacombe, D. | en |
dc.contributor.author | Bachmann, P. | en |
dc.contributor.author | Fumoleau, P. | en |
dc.creator | Briassoulis, E. Ch | en |
dc.creator | Pavlidis, Nicholas | en |
dc.creator | Terret, C. | en |
dc.creator | Bauer, J. | en |
dc.creator | Fiedler, W. | en |
dc.creator | Schöffski, P. | en |
dc.creator | Raoul, J. L. | en |
dc.creator | Hess, D. | en |
dc.creator | Selvais, R. | en |
dc.creator | Lacombe, D. | en |
dc.creator | Bachmann, P. | en |
dc.creator | Fumoleau, P. | en |
dc.date.accessioned | 2018-06-22T09:52:44Z | |
dc.date.available | 2018-06-22T09:52:44Z | |
dc.date.issued | 2003 | |
dc.identifier.uri | https://gnosis.library.ucy.ac.cy/handle/7/41478 | |
dc.description.abstract | The activity of glufosfamide (β-D-glucopyranosyl-N,N′ -di-(2-chloroethyl)-phosphoric acid diamide) against pancreatic cancer was investigated in a multicentre, phase II clinical study. Chemotherapy-naïve patients with advanced or metastatic disease were treated with glufosfamide (5 g/m2) using a 1-h intravenous (i.v.) infusion every 3 weeks. Patients were randomised between active-hydration and normal fluids to evaluate the nephroprotective effect of forced diuresis. Patients experiencing >0.4 mg/dl (>35 μmol/l) increase in serum creatinine compared with their baseline value were taken off treatment for safety reasons. The evaluation of response was according to the Response evaluation criteria in solid tumours (RECIST). Blood sampling was performed for pharmacokinetic analyses. 35 patients from 13 institutions were registered over a 13-month period. A total of 114 treatment cycles (median 3, range 1-8) were administered to 34 patients; 18 patients were allocated to the hydration arm. Overall haematological toxicity was mild. Metabolic acidosis occurred in 2 patients treated in the active-hydration arm, grade 3 hypokalaemia was recorded in 5 patients and grade 3 hypophosphataemia in 4 patients. One patient had a grade 4 increase in serum creatinine level, concomitantly to disease progression. Active-hydration did not show a nephroprotective effect and the plasma pharmacokinetics (Pk) of glufosfamide was not significantly influenced by hydration. Two confirmed partial remissions (PR) were reported (response rate 5.9%, 95% Confidence Interval (CI) 0.7-19.7%) and 11 cases obtained disease stabilisation (32.4%). An extra mural review panel confirmed all of the responses. Median overall survival was 5.3 months (95% CI 3.9-7.1) and time to progression (TTP) was 1.4 months (95% CI 1.3-2.7). In conclusion, glufosfamide administered using a 1-h infusion every 3 weeks has a modest activity in advanced pancreatic adenocarcinoma. Haematological toxicity is particularly mild, but regular monitoring of renal function is recommended. © 2003 Elsevier Ltd. All rights reserved. | en |
dc.language.iso | eng | en |
dc.source | European journal of cancer | en |
dc.subject | Article | en |
dc.subject | Cancer chemotherapy | en |
dc.subject | Human | en |
dc.subject | Adult | en |
dc.subject | Aged | en |
dc.subject | Cancer patient | en |
dc.subject | Controlled study | en |
dc.subject | Female | en |
dc.subject | Advanced cancer | en |
dc.subject | Cancer growth | en |
dc.subject | Cancer survival | en |
dc.subject | Chemotherapy | en |
dc.subject | Drug response | en |
dc.subject | Priority journal | en |
dc.subject | Alopecia | en |
dc.subject | Anemia | en |
dc.subject | Clinical article | en |
dc.subject | Clinical trial | en |
dc.subject | Controlled clinical trial | en |
dc.subject | Diarrhea | en |
dc.subject | Drug effect | en |
dc.subject | Drug infusion | en |
dc.subject | Drug safety | en |
dc.subject | Fatigue | en |
dc.subject | Leukopenia | en |
dc.subject | Multicenter study | en |
dc.subject | Neutropenia | en |
dc.subject | Phase 2 clinical trial | en |
dc.subject | Thrombocytopenia | en |
dc.subject | Randomized controlled trial | en |
dc.subject | Survival rate | en |
dc.subject | Metastasis | en |
dc.subject | Confidence interval | en |
dc.subject | Solid tumor | en |
dc.subject | Male | en |
dc.subject | Side effect | en |
dc.subject | Unclassified drug | en |
dc.subject | Blood toxicity | en |
dc.subject | Nausea | en |
dc.subject | Survival time | en |
dc.subject | Chemotherapy induced emesis | en |
dc.subject | Electrolyte disturbance | en |
dc.subject | Hypokalemia | en |
dc.subject | Disease severity | en |
dc.subject | Drug activity | en |
dc.subject | Beta dextro glucopyranosyl n | en |
dc.subject | Drug blood level | en |
dc.subject | Hypophosphatemia | en |
dc.subject | Metabolic acidosis | en |
dc.subject | N' bis(2 chloroethyl)phosphoric acid diamide | en |
dc.subject | Cancer regression | en |
dc.subject | Blood sampling | en |
dc.subject | Diuresis | en |
dc.subject | Arm | en |
dc.subject | Comparative study | en |
dc.subject | Creatinine | en |
dc.subject | Creatinine blood level | en |
dc.subject | D-19575 | en |
dc.subject | Drug screening | en |
dc.subject | Evaluation | en |
dc.subject | Glucopyranoside | en |
dc.subject | Glucosfamide | en |
dc.subject | Hematuria | en |
dc.subject | Hydration | en |
dc.subject | Kidney | en |
dc.subject | Kidney disease | en |
dc.subject | Kidney function | en |
dc.subject | Metabolic disorder | en |
dc.subject | Pancreas adenocarcinoma | en |
dc.subject | Pancreatic-cancer | en |
dc.subject | Phase ii | en |
dc.subject | Primary health care | en |
dc.subject | Protection | en |
dc.subject | Proteinuria | en |
dc.subject | Recording | en |
dc.title | Glufosfamide administered using a 1-hour infusion given as first-line treatment for advanced pancreatic cancer. A phase II trial of the EORTC-new drug development group | en |
dc.type | info:eu-repo/semantics/article | |
dc.identifier.doi | 10.1016/S0959-8049(03)00629-4 | |
dc.description.volume | 39 | |
dc.description.issue | 16 | |
dc.description.startingpage | 2334 | |
dc.description.endingpage | 2340 | |
dc.author.faculty | Ιατρική Σχολή / Medical School | |
dc.author.department | Ιατρική Σχολή / Medical School | |
dc.type.uhtype | Article | en |
dc.contributor.orcid | Pavlidis, Nicholas [0000-0002-2195-9961] | |
dc.gnosis.orcid | 0000-0002-2195-9961 |
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