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Monoclonal Antibodies

CAPOX + Bevacizumab + Trastuzumab for Stomach Cancer

Phase 2
Waitlist Available
Led By Peter Enzinger, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Confirmed HER2-positive esophageal, GE junction or gastric adenocarcinoma that is metastatic or unresectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 23.2 months (iqr: 11.0 - 46.9 months ).
Awards & highlights

Study Summary

This trial is testing a combination of chemotherapy drugs, capecitabine and oxaliplatin, plus the antibodies bevacizumab and trastuzumab to see if it is safe and effective.

Who is the study for?
This trial is for adults with HER2-positive metastatic esophagogastric cancer. Participants must have a tumor sample available, measurable disease, and be in good physical condition (ECOG 0 or 1). They should not have had certain previous cancer treatments and must agree to use contraception. People with serious wounds, recent surgeries, uncontrolled illnesses, known allergies to study drugs or components like Chinese hamster ovary cells are excluded.Check my eligibility
What is being tested?
The trial tests the effectiveness of CAPOX chemotherapy (capecitabine and oxaliplatin) combined with two antibodies: Bevacizumab which cuts off blood supply to tumors; Trastuzumab targeting HER2 protein on tumor cells. The goal is to see if this combination can effectively treat patients.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs due to antibody presence, bleeding issues from Bevacizumab's effect on blood vessels, heart problems from Trastuzumab's action on HER2 proteins as well as typical chemotherapy-related fatigue, digestive disturbances and nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is HER2-positive and cannot be removed by surgery.
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My cancer in the esophagus or stomach can be biopsied.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients received a median of 19 cycles of therapy (interquartile range (iqr): 8 - 34.5 cycles). median duration of follow-up of 23.2 months (iqr: 11.0 - 46.9 months ).
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients received a median of 19 cycles of therapy (interquartile range (iqr): 8 - 34.5 cycles). median duration of follow-up of 23.2 months (iqr: 11.0 - 46.9 months ). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Median Duration of Response (DOR)
Median Overall Survival
Median Progression Free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trastuzumab, Bevacizumab, Oxaliplatin and CapecitabineExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bevacizumab
2002
Completed Phase 3
~3360
trastuzumab
2002
Completed Phase 3
~1790
capecitabine
2002
Completed Phase 3
~2360
oxaliplatin
2002
Completed Phase 3
~6370

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,369 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,599 Previous Clinical Trials
11,462,477 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,918 Previous Clinical Trials
13,192,798 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment of participants for this trial still ongoing?

"According to clinicaltrials.gov, this particular study is no longer actively recruiting participants; it was initially posted on February 1st 2011 and the most recent update occurred July 18th 2022. Despite its status, there are a number of other trials currently enlisting candidates - 1533 in total."

Answered by AI

What medical applications is capecitabine most frequently employed for?

"Capecitabine has proven to be a useful therapy for refractory fallopian tube carcinoma, recurrent platinum-resistant epithelial ovarian cancer, and other malignant neoplasms."

Answered by AI

Have there been any other investigations concerning capecitabine?

"Currently, there is a wealth of studies examining the efficacy and safety profile of capecitabine. Specifically, 300 are in Phase 3 with 1002 still active overall. While primarily conducted at centres within Seattle, Washington, 47238 locations worldwide have joined this research initiative."

Answered by AI

How many participants are participating in the clinical experiment?

"This clinical trial has since closed, with the last data update occurring on July 18th 2022. For those interested in other medical opportunities, 531 trials for esophageal neoplasms malignant and 1002 trials for capecitabine are currently looking for participants."

Answered by AI

What adverse effects may ensue from capecitabine treatment?

"Capecitabine's safety was rated as a 2 since this is Phase 2 testing, indicating prior research has validated its security but not yet established its efficacy."

Answered by AI
~3 spots leftby Mar 2025