A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in High Grade Undifferentiated Uterine Sarcoma (HGUS) 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 sites78 target enrollmentJune 4, 2014

Overview

No summary available.

Registry

who.int

Start Date

June 4, 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:
•. Locally advanced: newly diagnosed high grade undifferentiated uterine sarcoma with advanced disease (stage III or stage IV) or residual disease after primary surgery
•. Metastatic: diagnosed high grade undifferentiated uterine sarcoma with disease relapse after local treatment for primary tumor
•\- 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
•\- Central pathological confirmation: Histological evidence of high grade undifferentiated uterine sarcoma

•At randomization
•\- The following tumor types are NOT eligible: low\-grade ESS, leiomyosarcoma (low, intermediate or high grade), carcinosarcoma, adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET of uterus/cervix.
•\- concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
•\- patient with poorly controlled hypertension defined at baseline as blood pressure (BP) \>150/90
•\- 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
•\- active peptic ulcer disease,