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IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01979393
Recruitment Status : Active, not recruiting
First Posted : November 8, 2013
Last Update Posted : October 13, 2021
Sponsor:
Collaborators:
Gynecologic Oncology Group
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 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 Uterine Sarcoma (HGUtS) After Stabilization or Response to Doxorubicin +/- Ifosfamide Following Surgery or in Metastatic First Line Treatment
Study Start Date : February 2015
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


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



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.



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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:

  • 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
  • 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, HGESS, HGLMS and HG adenosarcoma
  • 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 ESS, leiomyosarcoma (low or intermediate), carcinosarcoma, low-grade adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET 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

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


Locations
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Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
France
Institut Bergonie
Bordeaux, France, 33076
Centre Georges-Francois-Leclerc
Dijon, France, 21079
Centre Leon Berard
Lyon, France, 69373
Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau
Nantes, France
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Spain
Hospital General Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitario San Carlos
Madrid, Spain, 28040
United Kingdom
Cambridge University Hospital NHS - Addenbrookes Hospital
Cambridge, United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow, United Kingdom
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Gynecologic Oncology Group
NHS Greater Glasgow and Clyde
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01979393    
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 13, 2021
Last Verified: October 2021
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:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms