Overview

This trial is active, not recruiting.

Condition advanced gastric cancer
Treatment docetaxel, capecitabine, cisplatin, bevacizumab
Phase phase 2
Sponsor Asan Medical Center
Collaborator Roche Pharma AG
Start date July 2010
End date December 2017
Trial size 31 participants
Trial identifier NCT01471470, AMC ONCGI-1003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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)

Primary Outcomes

Measure
R0 resection rate
time frame: Up to 4 weeks after surgery

Secondary Outcomes

Measure
Overall survival
time frame: Up to 3 years
Angiogenetic biomarkers
time frame: Baseline and 6 weeks after treatment
Progression-free survival
time frame: Up to 3 years
Toxicity
time frame: Up to 6 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
Principal investigator Yoon-Koo Kang, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Asan Medical Center.