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IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

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ClinicalTrials.gov Identifier: NCT01979393
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : October 12, 2016
Sponsor:
Collaborators:
Gynecologic Oncology Group
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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Brief Summary:

This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs that have effects on tumour growth, blood supply, invasion and spread.

Therefore, we want to find out whether taking cabozantinib after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy.

All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization or response to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).


Condition or disease Intervention/treatment Phase
Uterine Sarcoma Drug: Cabozantinib Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cabozantinib
Cabozantinib maintenance 60 mg daily for 2 years or until withdrawal criterion After documented disease progression (according to RECIST 1.1), the treatment will be unblinded. Subjects receiving cabozantinib shall be further treated at the investigator discretion.
 Drug: Cabozantinib
Experimental: Placebo
Placebo daily for 2 years or until withdrawal criterion. After documented disease progression (according to RECIST 1.1), the treatment will be unblinded. Subjects receiving placebo shall be offered the option of receiving cabozantinib up to further progression. This is not mandatory and treatment is at the investigator decision.
 Drug: Cabozantinib
Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 3.5 years from first patient in ]
    The primary endpoint is PFS rate at 4 months after randomization to cabozantinib or placebo


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 3.5 years from first patient in ]
  2. Overall survival [ Time Frame: 3.5 years from first patient in ]
  3. Response rate [ Time Frame: 3.5 years from first patient in ]
  4. Duration of response to cabozantinib [ Time Frame: 3.5 years from first patient in ]
  5. Response rate to anthracycline-based chemotherapy for the patients with measurable disease [ Time Frame: 3.5 years from first patient in ]
  6. Assessment of global health status/QoL scale [ Time Frame: 3.5 years from first patient in ]
    The primary health-related quality of life endpoint that is considered of interest for this study is the global health status/QoL scale

  7. Occurence of Adverse Events [ Time Frame: 3.5 years from first patient in ]
    This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced: newly diagnosed HGUS with advanced disease (stage III or stage IV) or residual disease after primary surgery
  • Metastatic: diagnosed with disease relapse after local treatment for primary tumor
  • at least 18 years old
  • written informed consent
  • Central pathological confirmation: Histological evidence of HGUS
  • Non-progressive patients (CR, PR, SD) at the end of the first line treatment (standard chemotherapy consisting of 4 to 6 cycles of anthracyclines alone or in combination with ifosfamide)
  • WHO/ECOG performance status 0-2
  • Adequate organ and bone marrow function within 3 days prior to the first dose of study treatment (Cabozantinib/placebo)
  • Clinically normal cardiac function
  • Women of child bearing potential must have a negative serum/urine pregnancy test within 3 days prior to the first dose of study treatment
  • adequate birth control measures

Exclusion Criteria:

  • low grade sarcoma (ESS & leiomyosarcoma), leiomyosarcoma (intermediate & high grade), carcinosarcoma, adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue Primitive Neuroectodermal Tumors of uterus/cervix.
  • contraindications to cabozantinib
  • not able to swallow and retain oral tablets
  • planned use of chemotherapy, radiation therapy, radionuclide treatment, small molecule tyrosine kinase inhibitor or hormonal therapy, and any other investigational agent (Cabozantinib/placebo) during the treatment period
  • 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 >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
  • Gastrointestinal disorders
  • patients with radiographic evidence of cavitating pulmonary lesion(s)
  • patients with tumor in contact with, invading or encasing any major blood vessels
  • patients evidence of tumor invading the GI tract
  • evidence of active bleeding or bleeding diathesis
  • hemoptysis ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment
  • signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
  • clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
  • prior major surgery or trauma within 6 weeks prior to first dose of study drug and any wound, fracture, or ulcer should be completely healed
  • concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979393


Contacts
Contact: Ellen Peeters +32 2 7741082 ellen.peeters@eortc.be
Contact: Vinciane Vinckx +32 2 7741032 vinciane.vinckx@eortc.be

Locations
Belgium
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium
Principal Investigator: Manon Huizing         
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Contact Person    33-556-333-333      
Principal Investigator: Anne Floquet         
Centre Georges-Francois-Leclerc Recruiting
Dijon, France, 21079
Principal Investigator: Nicolas Isambert         
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Contact Person    33-4-7878-2645      
Principal Investigator: Isabelle Ray-Coquard         
Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau Recruiting
Nantes, France
Principal Investigator: Emmanualle Bompas         
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Principal Investigator: Paolo Casali         
Netherlands
Academisch Medisch Centrum at University of Amsterdam Recruiting
Amsterdam, Netherlands, 1105 AZ
Principal Investigator: Anneke Westermann, MD         
Spain
Hospital General Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: Claudia Valverde         
Hospital Universitario San Carlos Recruiting
Madrid, Spain, 28040
Principal Investigator: Antonio Casado         
United Kingdom
Cambridge University Hospital NHS - Addenbrookes Hospital Recruiting
Cambridge, United Kingdom
Principal Investigator: Helena Earl         
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital Recruiting
Glasgow, United Kingdom
Principal Investigator: Nick Reed         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Gynecologic Oncology Group
NHS Greater Glasgow and Clyde
Investigators
Study Chair: Isabelle Ray-Coquard, MD Centre Léon Bérard, Lyon, France
Principal Investigator: Nicholas Reed, MD NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital , Glasgow, United Kingdom
More Information
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01979393     History of Changes
Other Study ID Numbers: EORTC-62113-55115
2013‐000762‐11 ( EudraCT Number )
UC1306 ( Other Identifier: GOG )
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Locally advanced
stage III
stage IV
 residual disease after primary surgery
newly diagnosed HGUS
Metastatic

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms