Back to results

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

Primary Purpose

Advanced Gastric Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Docetaxel, Capecitabine, Cisplatin, Bevacizumab

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Advanced gastric cancer, Neoadjuvant, Bevacizumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neoadjuvant

Arm Description

Outcomes

Primary Outcome Measures

R0 resection rate

R0 resection means complete resection of tumor.

Secondary Outcome Measures

Overall survival

Overall survival will be measured from the start of study treatment to documented death of any cause.

Progression-free survival

Time to progression will be measured from the start of study treatment to documented tumor progression.

Adverse Event

Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0

Angiogenetic biomarkers

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

Full Information

NCT ID

NCT01471470

First Posted

July 18, 2011

Last Updated

January 6, 2020

Sponsor

Asan Medical Center

Collaborators

Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT01471470

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

July 2010 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

Collaborators

Roche Pharma AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Gastric Cancer

Keywords

Advanced gastric cancer, Neoadjuvant, Bevacizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

neoadjuvant

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Docetaxel, Capecitabine, Cisplatin, Bevacizumab

Intervention Description

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)

Primary Outcome Measure Information:

Title

R0 resection rate

Description

R0 resection means complete resection of tumor.

Time Frame

Up to 4 weeks after surgery

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival will be measured from the start of study treatment to documented death of any cause.

Time Frame

Up to 3 years

Title

Progression-free survival

Description

Time to progression will be measured from the start of study treatment to documented tumor progression.

Time Frame

Up to 3 years

Title

Adverse Event

Description

Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0

Time Frame

Up to 28 days after end of treatment

Title

Angiogenetic biomarkers

Description

Time Frame

Baseline and 6 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoon-Koo Kang, MD, PhD

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs