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 - HGUtS Study

European Organisation for Research and Treatment of Cancer (EORTC)0 sites54 target enrollmentFebruary 19, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 19, 2015

End Date

TBD

Last Updated

7 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 register 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 (if not available, at least 1 haematoxylin/eosin and 15 unstained slides) 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
•Patients can be randomized within 12 weeks after last administration of 1st line treatment, before the start of protocol treatment.

•At randomization
•\- The following tumor types are NOT eligible: low\-grade ESS, leiomyosarcoma (low, or intermediate), carcinosarcoma, adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET of uterus/cervix.
•\- 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 \> 100mm 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 (DVT) 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.
•\- Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
•? Any of the following within 28 days before the first dose of study treatment
•\- known intra\-abdominal tumor/metastases invading GI mucosa