Predictive Role of Circulating Angiogenic Factors for Second-line Paclitaxel and Ramucirumab.

March 28, 2022 updated by: Prof. Gianluca Masi, University of Pisa

Prospective Study to Identify and Validate the Predictive Role of Circulating Angiogenic Factors in Patients With Metastatic Gastric Cancer Treated With Second-line Paclitaxel and Ramucirumab

The project is primarily aimed at identifying and subsequently validating the predictive role of plasma concentrations of VEGF-A (vascular endothelial growth factor A), VEGF-D (vascular endothelial growth factor D) and s-VEGFR2 (soluble Vascular Endothelial Growth Factor Receptor 2) measured prior to initiation and during second-line treatment with paclitaxel and ramucirumab in patients with unresectable gastric cancer pretreated with first-line chemotherapy.

For the primary endpoint, the efficacy parameter chosen is PFS, calculated from day 1 of treatment to date of progression or death.

Study Overview

Status

Recruiting

Conditions

Gastric Cancer Stage IV

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Pisa, Italy, 56126
    - Recruiting
    - University of Pisa
    - Contact:
      
      Gianluca Masi, M.D
      
      Phone Number: 0039050992466
      
      Email: gianluca.masi@unipi.it
    - Contact:
      
      Lorenzo Fornaro, M.D.
      
      Phone Number: 0039050992466
      
      Email: l.fornaro@ao-pisa.toscana.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enrolled are affected by metastatic gastro-oesophageal junction or stomach cancer, undergoing second-line treatment with the combination of paclitaxel and ramucirumab according to normal clinical practice

Description

Inclusion Criteria:

Histologically confirmed carcinoma of the stomach, cardia or gastroesophageal junction;
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;
Life expectancy >3 months;
Age >18 years;
Metastatic disease measurable or evaluable according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
Progression after previous first-line treatment with fluoropyrimidines and platinum derivative; previous neoadjuvant/adjuvant treatment terminated ≤6 months after instrumental evidence of relapse will be considered first-line treatment;
Prior treatment with trastuzumab in case of HER-2 (human epidermal growth factor receptor 2) positive disease, defined as a 3+ immunohistochemistry (IHC) or 2+ IHC score and subsequent gene amplification demonstrated by Fluorescent In Situ Hybridization (FISH);

Exclusion Criteria:

Previous treatment with ≥2 lines of systemic therapy for metastatic disease;
Symptomatic peripheral neuropathy ≥2 grades according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03;
Uncontrolled infections in active phase, disseminated intravascular coagulation in activity;
Clinically significant cardiovascular disease, such as cardiovascular accidents (less than 6 months after initiation of treatment), myocardial infarction (less than 6 months after initiation of treatment), unstable angina, chronic heart failure ≥2 New York Heart Association (NYHA) grade, uncontrolled arrhythmias;
Past (within 2 years of treatment initiation, except for curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix) or current history of malignancy other than gastric cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS Time Frame: PFS is defined as the time interval between the start of second-line treatment and documentation of disease progression or death (whichever occurs first), assessed up to 6 months for each enrolled patient.	Progression Free Survival	PFS is defined as the time interval between the start of second-line treatment and documentation of disease progression or death (whichever occurs first), assessed up to 6 months for each enrolled patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)