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Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)_MITO 26 (MITO 26)

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ClinicalTrials.gov Identifier: NCT02993705
Recruitment Status : Not yet recruiting
First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks.

Condition or disease Intervention/treatment Phase
Carcinosarcoma, Ovarian Carcinosarcomas Uterine Drug: Trabectedin Phase 2

Detailed Description:

This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma.

Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)_MITO 26
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: Trabectedin
Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.
Drug: Trabectedin
Other Name: Yondelis




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: three years ]
    The primary endpoint of this study is to evaluate the activity of trabectedin in terms of the objective response rate (ORR) in patients with advanced uterine and ovarian carcinosarcoma.


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: three years ]
  2. Progression Free Survival (PFS) [ Time Frame: three years ]
    the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression

  3. Overall Survival (OS) [ Time Frame: three years ]
  4. Adverse events [ Time Frame: three years ]
    Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy
  • No more than 2 previous chemotherapy lines
  • PS 0-2 (ECOG)
  • Age> 18
  • Measurable disease
  • Life expectancy of at least 3 months
  • Adequate organ functions:

    • Hematopoietic; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin ≥ 9 g/dL Hepatic; AST and ALT ≤ 1.5 times upper limit of normal (ULN)*; Protocol Version 1.0_05.09.2016 6 Alkaline phosphatase ≤ 2.5 times ULN*; Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 3 times ULN if liver metastases are present Renal; Creatinine Clearance ≥ 45 mL/min or Serum Creatinine ≤1.5 x ULN Serum Albumin >3.0 g/dL
  • Previous Brachytherapy treatment for uterine carcinosarcoma is allowed
  • No other invasive malignancy within the past 3 years except non-melanoma skin cancer
  • Written Informed Consent

Exclusion Criteria:

  • More than 2 previous chemotherapy lines
  • Single tumor lesion inside a previous irradiated filed
  • Pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test)
  • Active infection requiring antibiotics
  • Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Toxicity Criteria.
  • Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
  • Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives
  • Psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol

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): NCT02993705


Contacts
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Contact: Domenica Lorusso, MD +390223903697 domenica.lorusso@istitutotumori.mi.it
Contact: Elisa Grassi, SC +390223903818 trialcenter@istitutotumori.mi.it

Locations
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Italy
Domenica Lorusso Not yet recruiting
Milan, Italy, 20133
Contact: Domenica Lorusso, MD    +390223903697    domenica.lorusso@istitutotumori.mi.it   
Contact: Elisa Grassi, SC    +390223903818    elisa.grassi@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Domenica Lorusso, MD Fondazione IRCCS Istituto Nazionale Tumori

Publications of Results:

Other Publications:
Schoffski P, Casali PP, Taron M, et al. Impact of the DNA repair functionality on the outcome of sarcoma patients treated with trabectedin (ET-743). J Clin Oncol, 2006; 24 (18 Suppl):525s (Abstract#9522)

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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02993705     History of Changes
Other Study ID Numbers: INT 166-16
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinosarcoma
Mixed Tumor, Mullerian
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Connective and Soft Tissue
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents