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Phase II Study to Assess the Efficacy and Safety of Trastuzumab in Combination With Xelox as First-line Treatment of Patients With Advanced or Metastatic Gastric Cancer or Gastro-esophageal Junction, (HER2)-Positive.

Phase 2
18 Years
Open (Enrolling)
Stage IV Gastric Cancer With Metastasis

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Trial Information

Phase II Study to Assess the Efficacy and Safety of Trastuzumab in Combination With Xelox as First-line Treatment of Patients With Advanced or Metastatic Gastric Cancer or Gastro-esophageal Junction, (HER2)-Positive.

Gastric cancer worldwide is the second tumor incidence (10%). There are significant
geographical differences in Spain with an incidence of 15 cases/100,000 per year. Although
the incidence and mortality of gastric cancer (GC) have experienced a marked reduction in
the past 40 years, this disease remains a leading cause of cancer-related mortality,
accounting for more than 870,000 deaths worldwide in the year 2000.

Gastric cancer has a high mortality rate because usually diagnosed when in advanced stage
and in many cases has a high relapse rate. Advanced gastric cancer cases are considered to
be diagnosed with unresectable disease, either by having locally advanced disease (30% of
cases at diagnosis), or having metastatic disease (another 30%) and patients with relapses
(60% of resected). Thus, overall around 84% of patients with gastric cancer will have
advanced disease.

The only curative treatment so far is surgery. Thanks to early detection and implementation
of appropriate surgical techniques, survival has improved in some countries such as Japan
and Korea, being the rate of 5-year survival of 47%Over the years, a large number of studies
with a single agent chemotherapy has been shown that gastric cancer is a relatively
sensitive to chemotherapy. Based on these observations, the trend was the investigation of
the combination of chemotherapy agents.

Based on these results FDA and EMEA has approved capecitabine in the treatment of advance
gastric cancer combined with platinum.

Inclusion Criteria:

- Patients be able to grant a written informed consent or oral consent

- Age ≥18 years old

- Patients diagnosed with metastatic gastric or gastro-esophageal junction
adenocarcinoma (HER2-positive), unresectable and histologically confirmed Measurable
disease, following the new RECIST criteria,

- HER2 positive tumors (primary or metastatic) with overexpression HER2 determinated by
IHQ +++ (IHQ3+) o IHQ ++ confirmed by FISH/SISH positive (IHQ2+/FISH+)

- ECOG ≤ 2

- Patients of childbearing potential (< 12 months from last menstruation), they have
to use effective means of contraception

- Life expectancy more than 3 months

- Adequate renal function: calculated creatinine clearance > 50 mL/min

- Adequate liver function: AST and ALT ≤2.5 x LSN (5 x LSN with liver metastasis),
bilirubin 1,5 x LSN. alkaline phosphatase < 2,5 x LSN (≤ 5 x LSN with liver
metastasis o < 10 x LSN with bone metastases Adequate haematological function: Hb ≥9
g/dl, neutrophils ≥ 1,5 x 109 /l and platelets 100 x 109 /l.

- Normal Left Ventricle Fraction Ejection , LVEF> 50%

- Every patient should be treated and followed in his / her study site

Exclusion Criteria:

- Prior chemotherapy treatment for advanced/metastatic disease

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

- Patients with active gastrointestinal bleeding

- Prior chemotherapeutic treatment for advanced / metastatic disease

- Toxicity as a result of prior therapy (except alopecia)., for example.

- Neurology toxicity grade ≥2NCI-CTCAE

- Patients who received radiotherapy within 4 weeks prior to study treatment.

- Major surgical procedures within 4 weeks prior to treatment without a total surgical

- Past or current history of other malignancies (within the last 5-2 years prior to
treatment start), patients with curatively treated basal cell carcinoma of the skin
or in situ carcinoma of the cervix are eligible

- Active and clinically significant cardiovascular disease,

- History or current clinical evidence of brain metastasis

- Patients undergoing transplantation allogenic requiring immunosuppressive treatment

- Moderate or severe renal failure, creatinine clearance < 50 mL/min, calculated by

- Adequate liver function: bilirubin ≤1.5 x UL, GOT ( ASAT )/ GPT ( ALAT ) ≤2,5 LSN.
Liver metastasis ≤ 5 x LSN, FA ≤ de 2,5 feces el LSN.

- Adequate haematology function: neutrophils ≥ 1,5 x 109 /l and platelets 100 x 109

- Treatment with sorivudine and the analogous as brivudine.

- Dihydropyrimidine proven dehydrogenase deficiency (DPD).

- Patients who had received any drug, agent or investigational procedure, or who have
participated in another research study within 30 days prior to initiation of
treatment with study medication.

- Hypersensitivity to any of the study drugs

- Evidence of any other disease, metabolic dysfunction, physical examination finding or
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or puts the patient at high risk
for treatment-related complications

- Patients receiving chronic corticosteroid therapy or high dose (is allowed to use
inhaled steroids and cycle short treatment with oral steroids for prevention of
emesis or to stimulate appetite)

- Pregnancy and lactation

- Patients of childbearing potential not willing to use effective means of

- History of psychiatric disorders that the investigator considered clinically
significant, causing the patient give informed consent or interfere with compliance
with study procedures.

Type of Study:


Study Design:

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

Outcome Measure:

Overall Survival

Outcome Description:

Overall survival defined as the time from start of treatment until the patient's death

Outcome Time Frame:

up to 10 Months

Safety Issue:


Principal Investigator

Fernando Rivera NA, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sponsor represntative


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

August 2011

Completion Date:

February 2015

Related Keywords:

  • Stage IV Gastric Cancer With Metastasis
  • Gastric Cancer with Metastasis
  • HER2-positive
  • Stomach Neoplasms
  • Neoplasm Metastasis