CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer

NCT ID: NCT01191697

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2024-08-31

Brief Summary

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.

Detailed Description

• 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.

Conditions

Esophageal Cancer; Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

Given intravenously on day 1 of each cycle beginning cycle 2

trastuzumab

Intervention Type: DRUG

Given intravenously on day 1 of each treatment cycle

oxaliplatin

Intervention Type: DRUG

Given intravenously on day one of each cycle beginning cycle 2

capecitabine

Intervention Type: DRUG

Taken orally on days 1-14 of each cycle beginning cycle 2

Interventions

bevacizumab

Given intravenously on day 1 of each cycle beginning cycle 2

Intervention Type: DRUG

trastuzumab

Given intravenously on day 1 of each treatment cycle

Intervention Type: DRUG

oxaliplatin

Given intravenously on day one of each cycle beginning cycle 2

Intervention Type: DRUG

capecitabine

Taken orally on days 1-14 of each cycle beginning cycle 2

Intervention Type: DRUG

Other Intervention Names

Avastin; Herceptin; xeloda

Eligibility Criteria

Inclusion Criteria

• Confirmed HER2-positive esophageal, GE junction or gastric adenocarcinoma that is metastatic or unresectable.
• All patients must have available tumor sample (either paraffin block or 15 freshly cut, unstained slides) prior to study entry.

Part II: Patient must have primary esophagogastric tumor in place or other tumor that is accessible for mandatory biopsy.

• Measurable disease, defined in RECIST 1.1
• 18 years of age or older
• Life expectancy of greater than 12 weeks
• ECOG performance status of 0 or 1
• Organ and marrow function as outlined in the protocol
• Women of child-bearing potential and men must agree to use adequate contraception during study participation and for 30 days from the date of the last study drug administration.
• Part II only: Participant agrees to undergo mandatory pre and post loading dose of trastuzumab biopsy for correlative science.

Exclusion Criteria

• Prior therapy with any of the following; capecitabine, oxaliplatin, bevacizumab or trastuzumab is not allowed. May have received and completed adjuvant therapy at least 6 months prior to study entry or one prior therapy for metastatic disease as long as it did not include any of the above agents.
• Chemotherapy or radiotherapy to greater then 25% of bone marrow within 4 weeks prior to entering the study.
• Palliative radiation therapy to isolated bone metastasis within 2 weeks of initiating therapy.
• Major surgery, open biopsy, significant traumatic injury within 4 weeks prior to study entry,.
• Minor surgery, including placement of vascular access device within 7 days prior to the first dose of bevacizumab.
• Residual toxicity from prior chemotherapy and/or radiation therapy of Grade 2 or greater.
• Participants may not be receiving any concurrent investigational agents
• Active brain or other CNS metastasis by history or clinical examination.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine, bevacizumab or trastuzumab. No known allergy or hypersensitivity to Chinese hamster ovary, or any of the study agents. No known DPD deficiency.
• Warfarin is prohibited; anticoagulation using low molecular weight heparin is allowed.
• Uncontrolled, intercurrent illness
• Patients with a history of other malignancy are not eligible except for the following circumstances: disease-free for at least 3 years and are deemed to be at low risk for recurrence of that malignancy; cervical cancer in situ, basal cell or squamous cell carcinoma of the skin that was treated with curative intent within the past 5 years.
• Known HIV seropositivity, hepatitis C, acute or chronic hepatitis B or other serious active infection
• LVEF less than 50% as determined by MUGA scan or echocardiogram within 28 days prior to initiation of therapy
• Inadequately controlled hypertension
• History of prior hypertensive crisis or hypertensive encephalopathy
• History of any arterial thrombosis, CVA, TIA, MI or unstable angina in past 6 months.
• Evidence of bleeding diathesis or coagulopathy
• Serious, unhealed wounds, bone fractures or skin ulcers
• Pregnant or breast feeding
• Greater than grade 1 peripheral neuropathy at baseline
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Peter Enzinger, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Enzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

09-457

Identifier Type: -

Identifier Source: org_study_id