Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC): Her+XELOX

January 6, 2020 updated by: Yoon-Koo Kang, Asan Medical Center

A Phase II Study of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer

This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier due to unacceptable toxicity, disease progression, or consent withdrawal. Patients will continue to be treated with trastuzumab alone until disease progression, unacceptable toxicity or consent withdrawal after finishing a maximum 6 cycles of combination chemotherapy.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
  2. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI).
  3. HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2
  4. ECOG Performance status 0, 1 or 2
  5. Life expectancy of at least 3 months.
  6. Male or female. Age over 20 year.
  7. Signed informed consent.

Exclusion Criteria:

  1. Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed).
  2. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube).
  3. Patients with active (significant or uncontrolled) gastrointestinal bleeding.
  4. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE.
  5. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
  6. Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L.
  7. Serum bilirubin > 1.5 × upper limit of normal (ULN); or, AST or ALT > 2.5 × ULN (or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 × ULN (or > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone but no liver metastases); or, albumin < 25 g/L.
  8. Creatinine clearance < 60 mL/min. Other Study Drug-Related Exclusion Criteria
  9. History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
  10. Baseline LVEF < 50% (measured by echocardiography or MUGA).
  11. Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
  12. Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
  13. Clinically significant hearing abnormality.
  14. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  15. History or clinical evidence of brain metastases.
  16. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
  17. Positive serum pregnancy test in women of childbearing potential.
  18. Subjects with reproductive potential not willing to use an effective method of contraception.
  19. Received any investigational drug treatment within 4 weeks of start of study treatment.
  20. Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recovered from any acute toxicity).
  21. Major surgery within 4 weeks of start of study treatment, without complete recovery.
  22. History of HIV infection, Patients with known active infection with HBV, or HCV.
  23. Known hypersensitivity to any of the study drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Herceptin+XELOX
Drug: Herceptin+XELOX

Each 3-weekly cycle, with chemotherapy given for 6 cycles, and trastuzumab continued even after completion of the combination chemotherapy until disease progression

  • Trastuzumab: 8 mg/kg i.v. loading dose on day 1, followed by 6 mg/kg i.v.infusion every 3 weeks
  • Capecitabine: 1000 mg/m2 oral twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15)
  • Oxaliplatin 130 mg/m2 i.v. on day 1
Other Names:
  • Capecitabine
  • Oxaliplatin
  • Trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: 1 year
To evaluate the overall response rate for patients treated with trastuzumab combinated with capecitabine plus oxaliplatin.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year
Progression free survival
Time Frame: 1 year
1 year
Duration of response
Time Frame: 1 year
1 year
Time to progression
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2011

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (ESTIMATE)

July 19, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC1101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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