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

NCT01191697 | Completed Phase 2 Results DMC

• 1 other identifier: 09-457
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

HER2 positive

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

  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 ).

Secondary Outcomes (3)

• Median Overall Survival

  23.2 months (IQR: 11.0 - 46.9 months ).

• Median Duration of Response (DOR)

  23.2 months (IQR: 11.0 - 46.9 months ).

• Median Progression Free Survival (PFS)

  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 ).

Study Arms (1)

Trastuzumab, Bevacizumab, Oxaliplatin and Capecitabine

EXPERIMENTAL

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.

Drug: bevacizumab; Drug: trastuzumab; Drug: oxaliplatin; Drug: capecitabine

Interventions

bevacizumab DRUG

Given intravenously on day 1 of each cycle beginning cycle 2

Also known as: Avastin

Trastuzumab, Bevacizumab, Oxaliplatin and Capecitabine

trastuzumab DRUG

Given intravenously on day 1 of each treatment cycle

Also known as: Herceptin

Trastuzumab, Bevacizumab, Oxaliplatin and Capecitabine

oxaliplatin DRUG

Given intravenously on day one of each cycle beginning cycle 2

Trastuzumab, Bevacizumab, Oxaliplatin and Capecitabine

capecitabine DRUG

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

Also known as: xeloda

Trastuzumab, Bevacizumab, Oxaliplatin and Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Genentech, Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

Bevacizumab; Trastuzumab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Peter C. Enzinger, MD
• Organization: Dana-Farber Cancer Institute

peter_enzinger@dfci.harvard.edu

(877) 442-3342

Study Officials

• Peter Enzinger, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 31, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2021
• Study Completion: August 1, 2024
• Last Updated: November 3, 2025
• Results First Posted: September 5, 2023

Record last verified: 2025-09

Locations

US (2)