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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

Must not have

Palliative radiation therapy to isolated bone metastasis within 2 weeks of initiating therapy

Known allergy or hypersensitivity to Chinese hamster ovary, or any of the study agents, or known DPD deficiency

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 ).

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not allergic to Chinese hamster ovary cell products or the study drugs, and I do not have DPD deficiency.

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I have serious, unhealed wounds, fractures, or skin ulcers.

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I have lasting side effects from previous cancer treatments that are moderate to severe.

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I have active brain or CNS cancer spread.

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I am allergic to medications similar to capecitabine, bevacizumab, or trastuzumab.

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I am taking Warfarin.

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My high blood pressure is not well controlled.

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I do not have any uncontrolled illnesses.

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I have HIV, hepatitis B or C, or another serious infection.

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I have previously been treated with capecitabine, oxaliplatin, bevacizumab, or trastuzumab.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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I have mild to severe numbness, tingling, or pain in my hands or feet.

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I have issues with my upper GI tract or problems absorbing nutrients.

Timeline

Screening ~ 3 weeks3 visits

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 ).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Median Duration of Response (DOR)

Median Overall Survival

Median Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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