Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive (HerXO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fundación para el Progreso de la Oncología en Cantabria
ClinicalTrials.gov Identifier:
NCT01503983
First received: December 7, 2011
Last updated: March 24, 2014
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Stage IV Gastric Cancer With Metastasis
Drug: Trastuzumab
Drug: Capecitabine
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Fundación para el Progreso de la Oncología en Cantabria:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: up to 10 Months ] [ Designated as safety issue: No ]
    Overall survival defined as the time from start of treatment until the patient's death


Secondary Outcome Measures:
  • progression free survival [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Progression free survival defined as time from start of treatment until date of progression were observed according to RECIST 1.1

  • the time to progression [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Time to progression defined as time elapsed since the beginning of treatment until disease progression

  • duration of response [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Duration of response defined as the time since the objective complete or partial response until there is disease progression

  • time to response [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Time to response, defined as the time from initiation of treatment until objective complete or partial response


Estimated Enrollment: 51
Study Start Date: August 2011
Estimated Study Completion Date: May 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab+Oxaliplatine+capecitabine
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.
Drug: Trastuzumab
Trastuzumab: 8 mg/kg day 1 followed by 6 mg/kg every 3 weeks (i.v.)
Other Name: Herceptin
Drug: Capecitabine
Capecitabine: 1000 mg/m2/12h/days 1 - 14 every 3 weeks (v.o.)
Other Name: Xeloda
Drug: Oxaliplatin
Oxaliplatin: 130 mg/m2 in 2 h, day 1 / (i.v.) /every 3 weeks
Other Name: Oxaliplatino

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503983

Locations
Spain
Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain, 15405
Hospital Lucus Augusti de Lugo
Lugo, A Coruña, Spain, 27003
Hospital Provincial de Pontevedra
Pontevedra, Vigo, Spain, 36001
Hospital Juan Canalejo
A Coruña, Spain, 15006
Centro Oncológico de Galicia
A Coruña, Spain, 15009
Hospital de Basurto
Bilbao, Spain, 48013
Hospital Arnau de Vilanova de LLeida
Lleida, Spain, 25198
Hospital Gregorio Marañon
Madrid, Spain, 28009
Hospital La Paz
Madrid, Spain, 28046
Hospital de Orense
Orense, Spain, 32005
Hospital Universitario Cnetral de Asturias
Oviedo, Spain, 33006
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Hospital Xeral Cies
Vigo, Spain, 36204
Hospital de POVISA
Vigo, Spain, 36211
Hospital Do Meixoeiro
Vigo, Spain, 36200
Sponsors and Collaborators
Fundación para el Progreso de la Oncología en Cantabria
Investigators
Principal Investigator: Fernando Rivera NA, Doctor Sponsor represntative
  More Information

No publications provided

Responsible Party: Fundación para el Progreso de la Oncología en Cantabria
ClinicalTrials.gov Identifier: NCT01503983     History of Changes
Other Study ID Numbers: FUPOCAN-01-11, 2011-001231-23
Study First Received: December 7, 2011
Last Updated: March 24, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación para el Progreso de la Oncología en Cantabria:
Gastric Cancer with Metastasis
HER2-positive

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Oxaliplatin
Trastuzumab
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014