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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Dana-Farber Cancer Institute
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Genentech
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01191697
First received: August 27, 2010
Last updated: July 16, 2013
Last verified: July 2013

August 27, 2010
July 16, 2013
February 2011
December 2014   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine the major response rate of CAPOX plus bevacizumab plus trastuzumab for patients with HER2-positive metastatic or unresectable esophagogastric adenocarcinoma.
Same as current
Complete list of historical versions of study NCT01191697 on ClinicalTrials.gov Archive Site
  • Toxicity profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To determine the toxicity profile
  • Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine the duration of response
Same as current
Not Provided
Not Provided
 
CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer
Phase II Trial of CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer

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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
December 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: GI Research Line 617-632-5960
Contact: Eileen Regan, RN, OCN 617-632-3898 eileen_regan@dfci.harvard.edu
United States
 
NCT01191697
09-457
Yes
Peter C. Enzinger, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Genentech
Principal Investigator: Peter Enzinger, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP