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MITO ??? Phase II study on Trastuzumab as single agent in recurrent mucinous ovarian cancer Fondazione IRCCS Istituto Nazionale Tumori CARCINOMA OVAIO il punto di vista del patologo CARCINOMA MUCINOSO 75% mutazione attivazione di KRAS No mutazioni di BRAF 15-20%: amplificazione di HER2 che rappresenta un via alternativa di attivazione del pathway MAPK. KRAS e HER2 mutalmente esclusivi Gynecol. Oncol. 90),378,2003 BMC Cancer 9,433, 2009 Ann. Surg. Oncol. 188,,2388, 2011 J. Clin. Pathol. 65, 671, 2012 Study design This is a single arm, proof of concept, multicenter phase II trial evaluating the role of Trastuzumab as single agent in patients with recurrent mucinous ovarian cancer with HER2 overexpression. Patients recurring after platinum-based chemotherapy (with or without Bevacizumab), overexpressing HER 2, will be enrolled and treated with Trastuzumab 600 mg sc every 3 weeks until disease progression or unacceptable toxicity or patients refusal, whichever occurs first. MITO ??? Objectives Primary: Response Rate by Recist 1.1 criteria Secondary: • Progression free survival; • Overall survival; • Toxicity MITO ??? Protocol Criteria Inclusion Criteria • Patients with recurrent, mucinous ovarian cancer with HER2 overexpression; • Evaluable or measurable disease; • At least 1 platinum treatment; • No limitation in the number of previous chemotherapy lines; Exclusion Criteria • Contraindication to Trastuzumab use MITO ??? Statistical consideration The control group will be represented by the historical control of recurrent mucinous ovarian cancer. For these patients literature report <10% response rate to conventional chemotherapy. This phase II study has a Simon two-stage design, with a projected response rate of 10% for conventional chemotherapy and an increase up to 30% with Trastuzumab treatment. If 2 or more major response will be achieved among the first 17 patients treated, the enrolment will be extended to 37 patients. If 6 or more responses will observed among the 37 patients, the study will be considered to have a positive result and this regimen would be considered worthy of further testing in this disease. This design yielded power of 0.90 to discriminate between true response rate of 10% and 30%. Secondary objectives will be progression free survival, overall survival, toxicity. The total duration of the study is 5 years ( estimated accrual time 3 years, treatment phase 1 years, follow up 1 year). MITO ??? Administrative information Study Drug Trastuzumab supplied by Roche •Academic trial; •NCI of Milan sponsor; Insurance will be provided •Planned study start: April 2016 Contact: [email protected] [email protected] MITO ???