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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT02993705

Collaborator

(none)

Enrollment

Location

Arm

32.7

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

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)

Actual Study Start Date :

Feb 22, 2017

Actual Primary Completion Date :

Nov 13, 2019

Actual Study Completion Date :

Nov 13, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR) [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

Duration of response [three years]
Progression Free Survival (PFS) [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
Overall Survival (OS) [three years]
Adverse events [three years]
Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) v 4.03.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome		Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Domenica Lorusso, Prof., Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Documents (Full-Text)

None provided.

More Information

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)

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT02993705

Other Study ID Numbers:

1561

First Posted:

Dec 15, 2016

Last Update Posted:

Aug 25, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinosarcoma

Mixed Tumor, Mullerian

Trabectedin

Study Results

No Results Posted as of Aug 25, 2021