Clinical Trials Directory

Trials / Completed

CompletedNCT00780494

Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma

A Phase II Study of Capecitabine, Carboplatin, and Bevacizumab for Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To investigate bevacizumab in combination with carboplatin and capecitabine for patients with unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to standard chemotherapy for this patient population we will improve Progression Free Survival by 90% over historical controls.

Detailed description

Primary Objectives: To investigate if the addition of Bevacizumab to standard chemotherapy for metastatic or unresectable GEJ and gastric adenocarcinoma will improve PFS by 90% over historical controls. Secondary Objectives: * Assess toxicities using CTCAE v3.0 * Evaluate overall survival (OS) using Kaplan-Meier analysis * Evaluate objective response rate (RR) by RECIST criteria * Explore biomarkers of tumor response: CEA, CA 19.9, and serum VEGF * Bank serum and tissue for future correlative studies * Evaluate CT Perfusion to predict early therapeutic response to combination chemotherapy and anti-angiogenic therapy (OPTIONAL).

Conditions

Interventions

TypeNameDescription
DRUGbevacizumabIntravenous 15 mg/kg
DRUGcarboplatinAUC 6, Intravenously Day 1 every 21 days
DRUGcapecitabine850mg/m2, Orally twice daily days 1-14 every 21 days.

Timeline

Start date
2009-02-01
Primary completion
2017-12-31
Completion
2017-12-31
First posted
2008-10-27
Last updated
2025-01-14
Results posted
2019-09-18

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT00780494. Inclusion in this directory is not an endorsement.