CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer
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|ClinicalTrials.gov Identifier: NCT01191697|
Recruitment Status : Active, not recruiting
First Posted : August 31, 2010
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer||Drug: bevacizumab Drug: trastuzumab Drug: oxaliplatin Drug: capecitabine||Phase 2|
- We recommend that the participants have a vascular access device, more commonly known as a PORT, inserted prior to starting chemotherapy. A port is a small device that is inserted under the skin (usually near the collar bone) by a minor surgical procedure and is then connected to one of the large veins inside the chest. The port will be used to give the intravenous medications.
- During the first cycle, the participant will receive trastuzumab intravenously on Day 1. Cycle 2 will then start one week later. On this day, bevacizumab will be given intravenously first followed by trastuzumab and then oxaliplatin. The participant will then start taking capecitabine tablets orally twice a day for 14 days. Each treatment cycle is 21 days long.
- Participants will have the following tests and procedures at specific time points during study treatment; physical exam, blood tests, CT scan, MUGA scan or echocardiogram, and urine test.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Trastuzumab, Bevacizumab, Oxaliplatin and Capecitabine
Trastuzumab, Bevacizumab, Oxaliplatin and Capecitabine for patients with HER2-positive metastatic esophagogastric cancer. Each cycle is 21 days.
Cycle 1, Day 1 Trastuzumab (loading dose) 4mg/kg IV
Cycle 2, Day 1 and all Subsequent Cycles Bevacizumab (7.5mg/kg) IV Trastuzumab (6mg/kg) IV Oxaliplatin (130mg/m2) IV Capecitabine (1200mg/m2) PO (taken Days 1-14 of each cycle)
Patients remained on treatment until disease progression, intercurrent illness that prevented further administration of treatment, unacceptable adverse events, participant decision to withdraw consent or general or specific changes in the participant's condition that rendered the participant unacceptable for further treatment.
Given intravenously on day 1 of each cycle beginning cycle 2
Other Name: Avastin
Given intravenously on day 1 of each treatment cycle
Other Name: Herceptin
Given intravenously on day one of each cycle beginning cycle 2
Taken orally on days 1-14 of each cycle beginning cycle 2
Other Name: xeloda
- Response Rate [ Time Frame: 2 years ]To determine the major response rate of CAPOX plus bevacizumab plus trastuzumab for patients with HER2-positive metastatic or unresectable esophagogastric adenocarcinoma.
- Toxicity profile [ Time Frame: 2 years ]To determine the toxicity profile
- Duration of response [ Time Frame: 2 years ]Determine the duration of response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191697
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Peter Enzinger, MD||Dana-Farber Cancer Institute|