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Ramucirumab/Paclitaxel as Second-line Treatment in Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma With Integrative Genomic Analysis

NCT02628951 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-11-19

No results posted yet for this study

Summary

Vascular endothelial growth factor is expressed in gastric cancer, and expression has been associated with more aggressive clinical disease. Vascular endothelial growth factor expression has been noted in 51% of gastric cancer specimens in one series (versus no expression in normal epithelium or superficial gastritis). Vascular endothelial growth factor expression in resected gastric cancer is associated with tumor recurrence and shorter survival. Maeda et al. studied 95 gastric cancer patients following resection with curative intent, and noted a significantly shorter survival in 34 patients whose tumor endothelium expressed VEGF (as detected via immunohistochemistry) versus 61 patients without endothelial VEGF expression (p\<0.05). Yoshikawa and colleagues observed similar survival differences in resected gastric cancer patients based on levels of circulating (plasma) VEGF at time of resection. Circulating VEGF is significantly higher in gastric cancer patients versus those without neoplasia. Elevated circulating VEGF was also associated with shorter survival in a European cohort undergoing gastric cancer resection; there was no survival beyond 30 months in 24 patients with serum VEGF \>533 pg/mL versus a 30-month survival rate \>35% for 34 patients with VEGF levels below this threshold (p\<0.0001, log-rank test). Recently, Jüttner and colleagues noted reduced survival following R0 resection in gastric cancer patients whose tumors expressed VEGF-C or VEGF-D, with the most robust association between expression and reduced survival for patients whose tumors expressed both VEGF-C and VEGF-D.

Investigational inhibition of VEGF Receptor 2 in gastric cancer xenografts (TMK-1 cell line) is associated with reduced tumor growth. DC101 therapy in this model is associated with significant reductions in tumor vascularity (as measured by CD-31 expression) and increases in endothelial and tumor apoptosis.

The results of the REGARD and RAINBOW studies are consistent with the idea that tumor- related angiogenesis contributes to the pathophysiology of gastric cancer and demonstrate the ability of ramucirumab to represent an improvement in the care of patients with gastric cancer whose disease has progressed after prior chemotherapy.

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Ramucirumab

Ramucirumab injection for intravenous (I.V.) use, supplied in single-use 500-mg/50-mL vials containing 10 mg/mL of product in histidine buffer, administered as an I.V. infusion after dilution at 8 mg/kg every 2 weeks in the absence of disease progression, toxicity requiring cessation, or withdrawal for any other reason.

DRUG

Paclitaxel

Paclitaxel will be administered at a dose of 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle in the absence of disease progression, toxicity requiring cessation, or withdrawal for any other reason.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-26
Primary Completion
2019-01-02
Completion
2019-01-02

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02628951 on ClinicalTrials.gov