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A Multicenter, Phase I-II Trial of Gemcitabine Plus Oxaliplatin and Nab-paclitaxel in Subjects With Advanced (Unresectable or Metastatic) Biliary Tract Cancer - ONC-2016-001

Studio Clinico

Patologia: Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I, II

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Written, signed informed consent
- Male or female aged 18 years or older
- Histologically or citologically-confirmed advanced (unresectable or metastatic) BTC (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
- Measurable or evaluable but non-measurable disease according to RECIST v. 1.1
- Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 6 months before the trial entry is accepted)
- Adequate bone marrow, liver, and renal function
- ECOG PS 0-1
- Life expectancy of at least 12 weeks
- Negative serum pregnancy test for women of childbearing potential;
- Adoption of adequate contraceptive methods when applicable Women of child-bearing potential must use the following adequate contraceptive methods during all the study and for 1 month after completion of study treatment: abstinence, tubal ligation, oral contraception or transdermal contraceptives, copper intrauterine device, vasectomy of the partner. For male patients with female partners of childbearing potential, agreement to use a barrier method of contraception from the first dose of treatment and for 6 months after completion of study treatment.
- Male patients mustn't donate sperm during the treatment with nab-paclitexel and for 6 months after completion of study treatment.
- Agreement not to donate blood during the study.

Criteri di esclusione: 

- Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as moderate symptoms; limiting instrumental activities of daily living (ADLs)
- Previous systemic treatment for advanced disease
- Known symptomatic brain metastases or carcinomatous meningitis
- Severe or uncontrolled systemic disease and/or active or uncontrolled infection
- Women who are currently pregnant or breast feeding
- Previous or current malignancies of other histologies within the last 3 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- Known hypersensitivity to nab-paclitaxel, gemcitabine, oxaliplatin or any of the excipients.

Trattamento sperimentale: 

Combination at different dose of gemcitabine, oxaliplatin and nab-paclitaxel

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The objective of the study is to determine a new combination of drug that improves the outcome in patients with advanced (unresectable or metastatic) BTC. The primary objective of the phase I part of the study is to determine the maximum tolerated dose (MTD) of the combination gemcitabine plus oxaliplatin plus nab-paclitaxel, established in the first cycle of therapy, in order to determine the recommended phase II dose (RP2D).
The primary objective of the phase II is to determine activity of GEMOX plus nab-paclitaxel.

Obiettivi secondari dello studio: 

The secondary objectives of the study consist in to better define the safety profile and the outcome of the study treated population.

Centri partecipanti

Nord Italia

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282246280
Email: armando.santoro@cancercenter.humanitas.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Oncologia 1

Email: oncologia1@iov.veneto.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-004118-84

Data di inserimento: 14.11.2019

Promotore

Istituto Clinico Humanitas

CRO

/

Principal Investigator ITALIA

Istituto Clinico Humanitas, Rozzano (Mi)

Riferimento: Prof. Armando Santoro

Telefono: 0282246280

Email: armando.santoro@cancercenter.humanitas.it

Localita: Rozzano (Mi)

 

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