Spots Global Cancer Trial Database for Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer
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Trial Identification
Brief Title: Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer
Official Title: Multicenter, Randomized, Non-comparative, Phase II Trial on the Efficacy and Safety of the Combination of Bevacizumab and Trabectedin With or Without Carboplatin in Adult Women With Platinum Partially Sensitive Recurring Ovarian Cancer.
Study ID: NCT01735071
Conditions
Study Description
Brief Summary: This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or second) platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, , Italy
AO Fatebenefratelli e Oftalmico, Milano, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Azienda Ospedaliera S. Gerardo, Monza, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Policlinico Universitario Agostino Gemelli di Roma, Roma, , Italy
Mauriziano Hospital, Torino, , Italy
Contact Details
Name: Nicoletta Colombo, Medical D
Affiliation: IRCCS Istituto Europeo di Oncologia di Milano
Role: PRINCIPAL_INVESTIGATOR
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