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

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. Identifier: NCT01396707
Recruitment Status : Active, not recruiting
First Posted : July 19, 2011
Last Update Posted : July 17, 2017
Hoffmann-La Roche
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic or Recurrent Gastric Adenocarcinoma Her-2 Positive Gastric Cancer Drug: Herceptin+XELOX Phase 2

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Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier due to unacceptable toxicity, disease progression, or consent withdrawal.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  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer
Study Start Date : June 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

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:
  • Trastuzumab
  • Capecitabine
  • Oxaliplatin

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 1 year ]
    To evaluate the overall response rate for patients treated with trastuzumab combinated with capecitabine plus oxaliplatin.

Secondary Outcome Measures :
  1. Duration of response [ Time Frame: 1 year ]
  2. Time to progression [ Time Frame: 1 year ]
  3. Progression free survival [ Time Frame: 1 year ]
  4. Overall survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01396707

Korea, Republic of
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Hoffmann-La Roche
Principal Investigator: Yoon-Koo Kang, MD, PhD Asan Medical Center


Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center Identifier: NCT01396707     History of Changes
Other Study ID Numbers: AMC-ONCGI-1101
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yoon-Koo Kang, Asan Medical Center:

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents