A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in High Grade Uterine Sarcoma (HGUtS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment

European Organisation for Research and Treatment of Cancer (EORTC)0 sites115 target enrollmentAugust 22, 2014

Overview

No summary available.

Registry

who.int

Start Date

August 22, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

European Organisation for Research and Treatment of Cancer (EORTC)

•1\) At registration:
•Patients can be registered no earlier than 4 weeks prior to start of the 1st line treatment and no later than 4 weeks after last administration of 1st line treatment.
•\- Patients who are suitable for treatment with doxorubicin \+/\- ifosfamide and fall within one of the following patient populations:
•? HGUS, HGESS, HGLMS and HG adenosarcoma
•? FIGO stage II and stage III : if adjuvant chemotherapy is proposed
•? FIGO stage IV: if first line chemotherapy is proposed
•\- 1 formalin fixed paraffin embedded block of tumor tissue is sent after registration of a patient. Histological central review is mandatory to confirm histology and grade.
•\- Patients must be at least 18 years old
•\- Before patient registration, written informed consent for central collection of tissue block or slides and any other trial\-specific procedures must be obtained
•2\) At Randomization

•At Registration
•? The following tumor types are NOT eligible: low\-grade ESS, leiomyosarcoma (low or intermediate), carcinosarcoma, low\-grade adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET of uterus/cervix.
•At randomization
•\- Prior treatment with cabozantinib
•\- history of congenital long QT syndrome
•\- concurrent severe, clinically relevant hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
•\- patient with concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic or \> 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;
•\- concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors
•\- patients who have suffered a cerebrovascular accident at any time in the past, patients who have suffered a transient ischemic attack in the past 6 months, patients who have suffered a deep venous thrombosis or a pulmonary embolism in the past 6 months
•note: Patients with recent DVT who have been treated with therapeutic anti\-coagulating agents and remained stable for at least 6 weeks are eligible: subjects with a venous filter are not eligible for this study