CAPOX + Bevacizumab + Trastuzumab for Stomach Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byPeter Enzinger

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy, capecitabine and oxaliplatin, plus the antibodies bevacizumab and trastuzumab. Trastuzumab (also called Herceptin) is an antibody that attacks HER2 protein in tumor cells. Bevacizumab (also called Avastin) works by slowing or stopping the growth of cells in cancer tumors by decreasing the blood supply of the tumors. If blood supply is decreased, oxygen and nutrients that are needed for tumor growth are decreased. The chemotherapy used in this trial is called CAPOX, which is an abbreviation of capecitabine and oxaliplatin.

Eligibility Criteria

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.

Inclusion Criteria

Measurable disease, defined in RECIST 1.1

Life expectancy of greater than 12 weeks

I am 18 years old or older.

+7 more

Exclusion Criteria

Receiving any concurrent investigational agents

I have received radiation for bone metastasis within the last 2 weeks.

I had minor surgery or a device placed for treatment within the last week.

+20 more

Participant Groups

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.

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.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺 Approved in European Union as Avastin for: