NCT01359397

Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer

Phase II Study of Docetaxel, Oxaliplatin, Capecitabine With Bevacizumab and Trastuzumab in Case of Human Epidermal Growth Factor Receptor 2 (HER2)-Positivity in Patients With Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT Study)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: It is estimated that in the Netherlands each year approximately 900 patients with gastric cancer or adenocarcinoma of the gastro-oesophageal junction are candidates for chemotherapy. Randomized studies comparing chemotherapy versus best supportive care have shown that survival and quality of life are prolonged with chemotherapy. However, no chemotherapy regimen is clearly superior with regard to prolongation of survival. Therefore, tolerability of treatment and ease of administration (outpatient compared to inpatient) are important considerations for the development of novel treatment schedules. Study design: This is an open-label, multicentre, phase II trial designed to evaluate the efficacy and safety of bevacizumab in combination with docetaxel, oxaliplatin and capecitabine chemotherapy (B-DOC) as first-line therapy in patients with inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. In case of HER2 positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction trastuzumab is added to this regimen (B-DOCT). Study Endpoints: Primary endpoint Progression free survival defined as the time measured from B-DOCT study, Protocol version 3.0 dated January 18, 2011 Page 5 / 60 the day of registration to first progression or death. Secondary endpoints Toxicity Overall survival, defined as the time from registration to death Response rate defined as the percentage of partial and complete responses Duration of response defined as time from response to first progression Translational research on pharmacogenomic and biological factors that may predict treatment response.

Conditions

• Metastatic Gastric Cancer
• Adenocarcinoma of the Gastro-oesophageal Junction

Interventions

Type	Name	Description
DRUG	Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab	Her2 - patients only
DRUG	Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab	for Her2 + patients only

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-05-01
• First posted: 2011-05-24
• Last updated: 2021-01-27

Locations

1 site across 1 country: Netherlands