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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191697
First Posted: August 31, 2010
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Genentech, Inc.
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute
  Purpose
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.

Condition Intervention Phase
Esophageal Cancer Gastric Cancer Drug: bevacizumab Drug: trastuzumab Drug: oxaliplatin Drug: capecitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer

Resource links provided by NLM:


Further study details as provided by Peter C. Enzinger, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 2 years ]
    To determine the major response rate of CAPOX plus bevacizumab plus trastuzumab for patients with HER2-positive metastatic or unresectable esophagogastric adenocarcinoma.


Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: 2 years ]
    To determine the toxicity profile

  • Duration of response [ Time Frame: 2 years ]
    Determine the duration of response


Estimated Enrollment: 36
Study Start Date: February 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bevacizumab
    Given intravenously on day 1 of each cycle beginning cycle 2
    Other Name: Avastin
    Drug: trastuzumab
    Given intravenously on day 1 of each treatment cycle
    Other Name: Herceptin
    Drug: oxaliplatin
    Given intravenously on day one of each cycle beginning cycle 2
    Drug: capecitabine
    Taken orally on days 1-14 of each cycle beginning cycle 2
    Other Name: xeloda
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191697


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Genentech, Inc.
Investigators
Principal Investigator: Peter Enzinger, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01191697     History of Changes
Other Study ID Numbers: 09-457
First Submitted: August 27, 2010
First Posted: August 31, 2010
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Peter C. Enzinger, MD, Dana-Farber Cancer Institute:
HER2 positive

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Bevacizumab
Oxaliplatin
Capecitabine
Trastuzumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action