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

Phase 2
20 Years
Open (Enrolling)
Metastatic or Recurrent Gastric Adenocarcinoma, Her-2 Positive Gastric Cancer

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Trial Information

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

Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier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

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

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

19. Received any investigational drug treatment within 4 weeks of start of study

20. Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if
palliative radiotherapy given to bone metastastic 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall reseponse rate

Outcome Description:

To evaluate the overall reseponse rate for patients treated with trastuzumab combinated with capecitabine plus oxaliplatin.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Yoon-Koo Kang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

December 2012

Related Keywords:

  • Metastatic or Recurrent Gastric Adenocarcinoma
  • Her-2 Positive Gastric Cancer
  • HER2
  • Trastuzumab
  • PHASE 2
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms