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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.
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Objectives
Primary:
Response Rate by Recist 1.1 criteria
Secondary:
• Progression free survival;
• Overall survival;
• Toxicity
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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
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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 ???