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

Primary Purpose

Carcinosarcoma, Ovarian, Carcinosarcomas Uterine

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Trabectedin

About this trial

This is an interventional treatment trial for Carcinosarcoma, Ovarian

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trabectedin

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)

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

Duration of response

Progression Free Survival (PFS)

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

Overall Survival (OS)

Adverse events

Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.

Full Information

NCT ID

NCT02993705

First Posted

December 1, 2016

Last Updated

August 24, 2021

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT02993705

Brief Title

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

Acronym

MITO 26

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

February 22, 2017 (Actual)

Primary Completion Date

November 13, 2019 (Actual)

Study Completion Date

November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinosarcoma, Ovarian, Carcinosarcomas Uterine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trabectedin

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Trabectedin

Other Intervention Name(s)

Yondelis

Intervention Description

Chemotherapy drug

Primary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

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.

Time Frame

three years

Secondary Outcome Measure Information:

Title

Duration of response

Time Frame

three years

Title

Progression Free Survival (PFS)

Description

Time Frame

three years

Title

Overall Survival (OS)

Time Frame

three years

Title

Adverse events

Description

Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.

Time Frame

three years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Domenica Lorusso, Prof.

Organizational Affiliation

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

City

Rome

ZIP/Postal Code

00168

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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

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