Clinical trial · Interventional
Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive
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.
NCT01503983CI-TRIAL-00018970HerXOcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of the study is assess the efficacy and safety of Trastuzumab in combination with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction, (HER2)-positive.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Gastric Cancer With Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab+Oxaliplatine+capecitabine
- description
- Patient takes Trastuzumab (initial dose 8 mg/kg and a maintenance dose 6 mg/kg) anda oxaliplatin (dose 130mg/m2) during the first day os cycle and them Capecitabine (dose 2000 mg/m2)during 14 days in cycle of 21 days.
- interventionNames
- Drug: Trastuzumab
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- up to 10 Months
- description
- Overall survival defined as the time from start of treatment until the patient's death
Secondary outcomes (4)
- measure
- progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 recovery. * 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 Cockcroft-Gault * 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 /l * 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 contraception. * History of psychiatric disorders that the investigator considered clinically significant, causing the patient give informed consent or interfere with compliance with study procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.