Phase I Study of Pegylated Liposomal Doxorubicin in Combination With Ifosfamide in Pretreated Ovarian Cancer Patients

2006 ◽  
Vol 29 (4) ◽  
pp. 399-404 ◽  
Author(s):  
Hugues Bourgeois ◽  
Florence Joly ◽  
Eric Pujade-Lauraine ◽  
Herv?? Cure ◽  
Jean Paul Guastalla ◽  
...  
2005 ◽  
Vol 11 (16) ◽  
pp. 5912-5919 ◽  
Author(s):  
Deepu Mirchandani ◽  
Howard Hochster ◽  
Anne Hamilton ◽  
Leonard Liebes ◽  
Herman Yee ◽  
...  

2014 ◽  
Vol 73 (5) ◽  
pp. 895-901 ◽  
Author(s):  
Tadahiro Shoji ◽  
Eriko Takatori ◽  
Yoshitaka Kaido ◽  
Hideo Omi ◽  
Yoshihito Yokoyama ◽  
...  

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 5530-5530
Author(s):  
Frédéric Selle ◽  
Anne Lesoin ◽  
Marie-Christine Kaminsky ◽  
Philippe Follana ◽  
Isabelle Ray-Coquard ◽  
...  

Author(s):  
Shunji Takahashi ◽  
Munetaka Takekuma ◽  
Kenji Tamura ◽  
Kazuhiro Takehara ◽  
Hiroyuki Nomura ◽  
...  

Abstract Background Advanced relapsed ovarian cancer has a poor prognosis, and treatment options are limited. Methods This phase I trial investigated the dosage, safety, pharmacokinetics and efficacy of trabectedin plus pegylated liposomal doxorubicin (PLD) in Japanese patients with advanced relapsed ovarian, fallopian tube, or primary peritoneal cancer. Patients received trabectedin 0.9 or 1.1 mg/m2 immediately after PLD 30 mg/m2; both drugs were given by intravenous infusion. Treatment was repeated every 21 days until disease progression or unacceptable toxicity. The maximum tolerated dose (MTD) was determined in an initial dose escalation phase, and this was used in a subsequent safety assessment phase. Safety and tumor response were monitored throughout the trial, and drug concentrations for pharmacokinetic analysis were measured during cycle 1. Results Eighteen patients were included. The MTD of trabectedin was determined as 1.1 mg/m2. Gastrointestinal adverse events were experienced by all patients, but were mostly grade 1 or 2 in intensity. Most patients had grade ≥ 3 elevations in transaminase levels or grade ≥ 3 reductions in neutrophil count, but these events were generally manageable through dose reduction and/or supportive therapies, as appropriate. There were no deaths during the trial. Trabectedin exposure increased in a dose-dependent manner. The overall response rate was 27.8%. Conclusions Trabectedin, in combination with PLD, may have clinical benefits in Japanese patients with relapsed advanced ovarian cancer. The recommended dosage of trabectedin for further study in this population is 1.1 mg/m2 once every 21 days. Clinical trial registration number: JapicCTI-163164


2019 ◽  
Vol 29 (1) ◽  
pp. 153-157 ◽  
Author(s):  
Elisa Tripodi ◽  
Gennaro Cormio ◽  
Ugo De Giorgi ◽  
Giorgio Valabrega ◽  
Daniela Rubino ◽  
...  

BackgroundPegylated liposomal doxorubicin (PLD) is an active and well-tolerable treatment in ovarian cancer relapse, either alone or in combination with other drugs. No data are available on the possibility to rechallenge PLD treatment in long survivor patients with recurrent ovarian cancer, as evaluated for platinum agent, paclitaxel and gemcitabine. The aim of the present study was to evaluate the anti-tumor activity and the toxicity profile of re-challenge of PLD in recurrent ovarian cancer patients.MethodsData on 27 patients with epithelial ovarian cancer treated in the last ten years (2007-2017) with palliative PLD rechallenge were included in this multicenter retrospective Italian study.ResultsThe objective response rate to PLD re-treatment were complete response in 19%, partial response in 30% and stable disease in 37%. Only 1 case of G4 hematological toxicity was reported. No patient experienced severe cardiac impairment (G2-4).ConclusionPLD rechallenge represents an active and safe possibility of treatment for long survivor ovarian cancer patients.


2018 ◽  
Vol 83 (1) ◽  
pp. 97-105 ◽  
Author(s):  
Kristina Lindemann ◽  
◽  
Philip J. Beale ◽  
Emma Rossi ◽  
Jeff C. Goh ◽  
...  

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