Neoplasms

All Conditions

Rare Diseases

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Neoplasms by Histologic Type

Sarcoma

Neoplasms, Connective and Soft Tissue

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Uterine Carcinosarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Trabectedin

Antineoplastic Agents, Alkylating

Alkylating Agents

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.

Domenica Lorusso, Prof.

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.

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.

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

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

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.

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

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Leiomyosarcoma

Endometrial Stromal Tumors

Neoplasms, Connective Tissue

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Sarcoma

Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.

Vorinostat Oral Capsule

Edgar Petru, MD

Uterine sarcomas are rare tumors with a poor prognosis.

The main purpose of this phase II proof-of-principle- pilot study is to test the efficacy of the hydroxamic acid-based Histone deacetylase inhibitor (HDACI) Vorinostat (SAHA) as monotherapy in patients with HDAC-positive, progressive, metastatic uterine sarcomas and mixed epithelial and mesenchymal tumors after prior anti-proliferative therapy.

This is an open-label, single arm, proof of concept-study of the HDAC-inhibitor vorinostat in patients with refractory uterine sarcoma that have been pre-tested for an high expression of HDAC. Patients will receive Vorinostat, 400 mg (4 capsules á 100mg of Zolinza) orally once daily for the first 14 days of a 21 day cycle. Treatment will be continued for 4 cycles (treatment period 1). Patients with a response or stable disease after 4 cycles as determined by computed tomography (CT) of target an non target-lesions will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a 9 months period (treatment periods 2 and 3).

The investigated condition occurs exclusively in women

Vorinostat (SAHA) in Uterine Sarcoma

A Pilot Study of Peroral Vorinostat (SAHA) in Patients With Refractory Histone Deacetylase-positive Uterine Sarcoma

Change from Baseline Tumor Size to last available observation with respect to progress as defined by RECIST 1.1 (CT-Scan every 12 weeks up to 9 months)

This endpoint is evaluated by the amount of clinical adverse experiences.

Medical University of Graz

Vorinostat Oral Capsules 400mg daily

Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.

Vorinostat, Zolinza Oral Capsules

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Austria

Region of Enrollment

Statistical evaluation was not possible as only 1 Patient reached end point 1.

Prof. Edgar Petru

Only one Patient reached the first end Point. Statistical Evaluation was therefore not possible. For this reason no data are reported in the data table.

Progression-free Survival (PFS)

Only one Patient reached the first end Point. Statistical Evaluation was therefore not possible.

For this reason no data are reported in the data table.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)	NCT02993705	Carcinosarcoma,... Carcinosarcomas...	Trabectedin	18 Years - 100 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Vorinostat (SAHA) in Uterine Sarcoma	NCT03509207	Leiomyosarcoma Endometrial Str... Carcinosarcomas...	Vorinostat Oral...	18 Years -	Medical University of Graz

Spots Global Cancer Trial Database for carcinosarcomas uterine