Document Detail

A phase Ib and pharmacokinetic trial of patupilone combined with carboplatin in patients with advanced cancer.
MedLine Citation:
PMID:  17634546     Owner:  NLM     Status:  MEDLINE    
PURPOSE: Patupilone is a microtubule-targeting chemotherapeutic agent with clinical activity in a broad range of taxane-sensitive/resistant tumor types. The present phase Ib study examined the safety/tolerability and pharmacokinetics of patupilone in combination with carboplatin in patients with advanced solid tumors. EXPERIMENTAL DESIGN: Patients with advanced cancer received patupilone via a 5- to 10-min i.v. infusion at doses of 3.6 to 6.0 mg/m(2) q3w, immediately followed by carboplatin area under the curve (AUC) 5 or 6 mg/mL/min. RESULTS: Of the 37 patients enrolled, the majority previously received taxanes (81%) and/or platinum-containing drugs (97.3%). The maximum tolerated dose (MTD) of patupilone with carboplatin AUC 6 was 4.8 mg/m(2); additional patients were enrolled to consolidate experience at this dose. Of the 22 patients who received the MTD, the most common nonhematologic adverse events were fatigue in six (27.3%) and diarrhea, nausea, vomiting, abdominal pain, and neuropathy in one each (4.5%; all grade 3); hematologic toxicities included two patients (9.1%) with grade 3 neutropenia. The pharmacokinetics of patupilone were similar to those in a previous study of patupilone monotherapy. Of the 26 patients with recurrent platinum-sensitive ovarian cancer, tumor response was assessable by response evaluation criteria in solid tumors in 17; 1 patient (6%) achieved a complete response, and 10 (59%) achieved a partial response. CONCLUSIONS: The combination of patupilone 4.8 mg/m(2)/carboplatin AUC 6 was well tolerated and showed antitumor activity similar to established regimens in patients with recurrent platinum-sensitive ovarian cancer. The optimal dose for this regimen is currently being further refined in phase II trials.
Martin Forster; Stan Kaye; Amit Oza; Ivo Sklenar; Anandhi Johri; Wing Cheung; Sara Zaknoen; Martin Gore
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article    
Journal Detail:
Title:  Clinical cancer research : an official journal of the American Association for Cancer Research     Volume:  13     ISSN:  1078-0432     ISO Abbreviation:  Clin. Cancer Res.     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-07-19     Completed Date:  2007-09-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9502500     Medline TA:  Clin Cancer Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  4178-84     Citation Subset:  IM    
Royal Marsden Hospital Gynecology Unit, London, United Kingdom.
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MeSH Terms
Antineoplastic Agents / pharmacokinetics,  toxicity*
Antineoplastic Combined Chemotherapy Protocols / pharmacokinetics,  therapeutic use*,  toxicity
Carboplatin / pharmacokinetics,  therapeutic use*
Epothilones / pharmacokinetics,  toxicity*
Gastrointestinal Neoplasms / drug therapy,  pathology
Middle Aged
Neoplasm Staging
Neoplasms / drug therapy*,  pathology
Ovarian Neoplasms / drug therapy,  pathology
Uterine Cervical Neoplasms / drug therapy,  pathology
Uterine Neoplasms / drug therapy,  pathology
Reg. No./Substance:
0/Antineoplastic Agents; 0/Epothilones; 0/epothilone B; 41575-94-4/Carboplatin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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