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

August 24, 2021 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phase II Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Chemotherapy drug
Other Names:
  • Yondelis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response
Time Frame: three years
three years
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
three years
Overall Survival (OS)
Time Frame: three years
three years
Adverse events
Time Frame: three years
Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2017

Primary Completion (Actual)

November 13, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimate)

December 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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