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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 : January 31, 2020
Sponsor:
Collaborators:
Gynecologic Oncology Group
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE November 4, 2013
First Posted Date  ICMJE November 8, 2013
Last Update Posted Date January 31, 2020
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
  • Progression free survival [ Time Frame: 3.5 years from first patient in ]
  • Overall survival [ Time Frame: 3.5 years from first patient in ]
  • Response rate [ Time Frame: 3.5 years from first patient in ]
  • Duration of response to cabozantinib [ Time Frame: 3.5 years from first patient in ]
  • Response rate to anthracycline-based chemotherapy for the patients with measurable disease [ Time Frame: 3.5 years from first patient in ]
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IRCI Gynae Sarcomas, High Grade Uterine Sarcoma
Official Title  ICMJE 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
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Uterine Sarcoma
Intervention  ICMJE
  • Drug: Cabozantinib
  • Drug: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Interventions:
    • Drug: Cabozantinib
    • Drug: Placebo
Publications * Ray-Coquard I, Hatcher H, Bompas E, Casado A, Westermann A, Isambert N, Casali PG, Pratap S, Stark D, Valverde C, Anand A, Huizing M, Floquet A, Lindner L, Hermes B, Seddon B, Coens C, Jones R, Reed N. A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma after stabilization or response to doxorubicin ± ifosfamide following surgery or in metastatic first line treatment (EORTC62113). Int J Gynecol Cancer. 2020 Oct;30(10):1633-1637. doi: 10.1136/ijgc-2020-001519. Epub 2020 Jun 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2013)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ellen Peeters +32 2 7741082 ellen.peeters@eortc.be
Contact: Vinciane Vinckx +32 2 7741032 vinciane.vinckx@eortc.be
Listed Location Countries  ICMJE Belgium,   France,   Italy,   Netherlands,   Spain,   United Kingdom
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT01979393
Other Study ID Numbers  ICMJE EORTC-62113-55115
2013-000762-11 ( EudraCT Number )
UC1306 ( Other Identifier: GOG )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE
  • Gynecologic Oncology Group
  • NHS Greater Glasgow and Clyde
Investigators  ICMJE
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
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP