Phase II Trial of Ramucirumab, Carboplatin, and Paclitaxel in Previously Untreated Thymic Carcinoma/B3 Thymoma With Area of Carcinoma - RELEVENT

Studio Clinico

Patologia: Timoma e carcinoma timico

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Informed consent form approved by institutional review board/institutional ethics committee and signed and dated
- Histologic diagnosis of advanced/recurrent/metastatic thymic carcinoma or Thymoma B3 with areas of carcinoma  Disease not amenable to curative intent therapy
- Age ≥ 18 y
- Blood and plasma samples collected at baseline and first re-evaluation of disease
- Availability of archived or fresh histologic material
- Presence of measurable disease
- Eastern Cooperative Oncology Group performance status 0 or 1

Criteri di esclusione: 

- Previous therapy for thymic carcinoma/thymoma B3 with areas of carcinoma
- Presence of untreated central nervous system metastases
- History of significant arterial or venous thrombosis
- Grade ≥ 2 peripheral neuropathy
- Major bleeding
- Radiologic evidence of intratumor cavitation, invasion of blood vessels, or encasement from cancer
- Uncontrolled or poorly controlled hypertension despite standard medical therapy

Numero di pazienti previsti: 

60

Schema di trattamento: 

Eligible patients will receive ramucirumab (10 mg/kg intravenously [IV]), paclitaxel (200 mg/m2 IV), and carboplatin (area under the curve, 5 IV) on day 1 of each 21-day cycle for a maximum of 6 cycles, unless evidence of disease progression is seen or intolerable toxicity ensues.
Patients completing chemotherapy combined with ramucirumab with evidence of radiologic disease control (complete response, partial response, stable disease) can continue to receive ramucirumab every 3 weeks as maintenance therapy until progressive disease, intolerable toxicity, or investigator/patient decision. Tumor assessments will be performed every 6 weeksduring treatment and then every 12 weeks during ramucirumab maintenance.

Trattamento sperimentale: 

Ramucirumab, Carboplatin, and Paclitaxel

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The RELEVENT trial is being performed to determine whether ramucirumab combined with carboplatin and paclitaxel is an active and safe first-line treatment for chemotherapy-naive patients with advanced TC or B3 thymoma with area of carcinoma.

Obiettivi secondari dello studio: 

The trial will also investigate possible biomarkers (mutations, polymorphisms, and circulating micro-RNA) associated with the response and will evaluate feasibility of PROMs.

Studi collaterali: 

The biologic study BIOTET will be conducted on all TETs with availability of fresh tissue and will provide new insights in the biology of all TETs through an extensive genomic, transcriptomic, proteomic, and metabolomic study.

Note generali: 

The RELEVENT trial is a joint effort of the centers of the Italian Network TYME (www.tyme.eu)

Data di inizio dell'arruolamento: 01.10.2018

Periodo previsto di arruolamento: 24 mesi

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-004494-13

Data di inserimento: 01.10.2018

Promotore

IRCCS Istituto Nazionale dei Tumori di Milano - Bando di Ricerca indipendente AIFA

Riferimento: Dr.ssa Marina Chiara Garassino

Telefono: 0223903813

Email: marina.garassino@istitutotumori.mi.it

Localita: Milano

CRO

IRCCS Istituto di ricerche farmacologiche Mario Negri

Principal Investigator ITALIA

Riferimento: Dr.ssa Marina Chiara Garassino

Telefono: 0223903813

Email: marina.garassino@istitutotumori.mi.it

Localita: Milano