Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer (B-DOCT)
|ClinicalTrials.gov Identifier: NCT01359397|
Recruitment Status : Unknown
Verified October 2015 by The Netherlands Cancer Institute.
Recruitment status was: Active, not recruiting
First Posted : May 24, 2011
Last Update Posted : November 4, 2015
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).
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Gastric Cancer Adenocarcinoma of the Gastro-oesophageal Junction||Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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)|
|Study Start Date :||March 2011|
|Primary Completion Date :||May 2015|
U.S. FDA Resources
|Active Comparator: Herceptin -||
Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab
Her2 - patients only
|Experimental: Herceptin +||
Drug: Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab
for Her2 + patients only
- Progression free survival [ Time Frame: Patients will be followed for an average period of 1 year ]the time measured from the day of registration to first progression or death
- Number of Participants with Serious Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Patients will be followed for an average period of 1 year ]Toxicity will be evaluated during/after every course. Patients having received ≥1 treatment doses are evaluable for toxicity. Evaluation will be performed on the safety population (having received treatment). Clinical and laboratory toxicity will be graded according to NCI common toxicity criteria, version 4.0.
- Overall survival [ Time Frame: 12 months ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359397
|Netherlands Cancer Institute|