Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer

January 6, 2020 updated by: Yoon-Koo Kang, Asan Medical Center

A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer

The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and bevacizumab are effective in the treatment of unresectable advanced gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In our previous phase II study of neoadjuvant docetaxel, capecitabine and cisplatin chemotherapy, patients with unresectable gastric cancer because of invasion to adjacent organs or metastasis to para-aortic lymph nodes received benefit from neoadjuvant chemotherapy. Based on these results and reports that bevacizumab enhances response rate, we planned docetaxel, capecitabine, cisplatin, and bevacizumab as neoadjuvant chemotherapy for patients with local invasion or para-aortic node metastasis alone.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

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

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically documented adenocarcinoma of the stomach or gastroesophageal junction.
  • Invasion to adjacent organ (T4) proven by endoscopic ultrasonography (EUS) or presence of paraaortic lymph node metastasis by CT and PET(short-axis diameter > 1 cm showing hot uptake in PET scan).
  • Age 18-70 years old
  • ECOG performance status 0-2
  • Adequate hepatic function(serum bilirubin <1.5mg/dl, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL)
  • Adequate renal function(serum creatinine <1.5mg/dl)
  • Adequate bone marrow function (WBC ≥4000 cell/㎕ with ANC ≥1500 cell/㎕, platelet count ≥100,000 cell/㎕)
  • HER2 negative (HER2 immunohistochemistry 0 or 1+, immunohistochemistry 2+ but FISH negative)
  • Informed consent

Exclusion Criteria:

  • Other histologic type than adenocarcinoma
  • Metastasis in other sites than paraaortic lymph nodes, like in liver or peritoneum.
  • Presence or history of other cancers
  • History of prior chemotherapy, antiangiogenic agents, or radiation.
  • Patients with definite ascites in abdomen CT scan
  • Presence of not adequately controlled CNS metastasis
  • Bowel obstruction
  • Evidence of gastrointestinal bleeding
  • Other serious illness or medical conditions including hypertension uncontrolled by medication.
  • Pregnant or lactating women

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neoadjuvant
Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab
Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: Up to 4 weeks after surgery
R0 resection means complete resection of tumor.
Up to 4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 3 years
Overall survival will be measured from the start of study treatment to documented death of any cause.
Up to 3 years
Progression-free survival
Time Frame: Up to 3 years
Time to progression will be measured from the start of study treatment to documented tumor progression.
Up to 3 years
Adverse Event
Time Frame: Up to 28 days after end of treatment
Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0
Up to 28 days after end of treatment
Angiogenetic biomarkers
Time Frame: Baseline and 6 weeks after treatment
cluster of differentiation 31, microvessel density, platelet derived growth factor, vascular endothelial growth factor-A, vascular endothelial growth factor receptor-1, vascular endothelial growth factor receptor-2, Neuropilin 1 and phosphatidylinositol glycan anchor biosynthesis, class F
Baseline and 6 weeks after treatment

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Collaborators

Roche Pharma AG

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)

July 1, 2010

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 15, 2011

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC1003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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