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MITO 26
PHASE II TRIAL ON TRABECTEDIN IN THE TREATMENT
OF ADVANCED UTERINE AND OVARIAN
CARCINOSARCOMA (CS)
Study design
This is a Phase II, multi-centre, single arm study aiming at evaluating
efficacy and toxicity of Trabectedin in a population of advanced or recurrent
uterine and ovarian carcinosarcoma.
A central revision of slides is required. Dr Carcangiu (NATIONAL CANCER
INSTITUTE OF MILAN) will provide the revision. For any patient 4 x 10 μm
unstained slides and 5x 4μm stained H&E slides must be provided .
Study Drug
Trabectedin 1.3 mg/mq iv (central line) d1 q 21 until progression of disease,
unacceptable toxicity or patient’s consent withdrawal
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Objectives
Primary:
•To determine the activity in terms of objective response rate by RECIST
version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in
patients with advanced uterine and ovarian carcinosarcoma
Secondary:
•Progression free survival;
•Overall survival;
•Duration of response;
•Toxicity.
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Inclusion Criteria
•Histologically documented Stage I-IV or recurrent uterine or ovarian
carcinosarcoma not amenable to surgery or radiotherapy;
•No more than 2 previous chemotherapy lines;
•PS 0-2 (ECOG);
•Age> 18;
•Measurable disease;
•Life expectancy of at least 3 months;
•Adequate organ functions;
•Previous Brachytherapy treatment for uterine carcinosarcoma is allowed;
•No other invasive malignancy within the past 3 years except non-melanoma skin
cancer;
•Written Informed Consent.
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Exclusion Criteria
•More than 2 previous chemotherapy lines;
•Single tumor lesion inside a previous irradiated filed;
•Pregnant (potentially fertile patients must be not in pregnancy during and for at
least 3 months after study participation and must have a negative serum
pregnancy test);
•Active infection requiring antibiotics;
•Symptomatic peripheral neuropathy > grade 2 according to the NCI Common
Toxicity Criteria;
•Congestive heart failure or angina pectoris even if it is medically controlled.
Previous history of myocardial infarction within 1 year from study entry,
uncontrolled high risk hypertension or arrhythmia;
•Unstable or severe intercurrent medical condition that, in the opinion of the
investigator, might interfere with achievement of study objectives;
•Psychological or sociological conditions, addictive disorders, or family problems,
which would preclude compliance with the protocol.
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Statistical consideration
This phase II, single-arm, open-label, non randomized trial was designed as a twostage sequential study with an early stopping rule in the event of insufficient
activity demonstrated by the treatment. The percentage of objective response in
patients with advanced or recurrent CSs which failed a previous platinum-based
chemotherapy treatment is around 10%. If after the first 13 patients are treated, at
least 1 response is achieved, then additional 22 patients will be enrolled.
If seven or more patients responded to the therapy after the second accrual stage,
the conclusion will be drawn that further investigation is warranted unless other
considerations (such as unacceptable toxicity) indicated otherwise. This procedure
will test the null hypothesis (h0) that the true response rate is ≤10% versus the
alternative hypothesis (ha) that the true response rate is at least 25%, with a
significance level of 0.06 and a power of 80%.
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Administrative Information
•Academic trial
•NCI of Milan sponsor
•Data center: NCI of Milan (MITO center)
•Planned study start: April 2016
•Pharmamar: drug supply
•Insurance provided by Coordinator center
To participate please contact:
[email protected]
[email protected]
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