A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01130337
First received: May 25, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This study will evaluate the disease free survival rate of a combination of cape citabine [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patien ts with resectable gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor. If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alo ne. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day

1 in every cycle. The anticipated time on study drug will be 12 months.


Condition Intervention Phase
Gastric Cancer
Drug: Capecitabine [Xeloda]
Drug: Oxalipatin
Drug: Trastuzumab [Herceptin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Study to Evaluate the Disease Free Survival Rate of a Perioperative Combination of Capecitabine (Xeloda), Trastuzumab (Herceptin) and Oxaliplatin (XELOX- Trastuzumab) in Patients With Resectable Gastric or Gasro-esophageal Junction Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease free survival defined as 18 months disease free survival rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathological response according to Mandard criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • R0 tumor resection rate [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Objective reponse rates according to RECIST criteria [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
  • Toxicity of treatment [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Capecitabine [Xeloda]
1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
Drug: Oxalipatin
130 mg/m2 intravenous infusion day 1 of every cycle
Drug: Trastuzumab [Herceptin]
First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles

  Eligibility

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

Inclusion Criteria:

  • Adult patients over 18 years of age
  • Locally advanced resectable HER2-positive gastric or esophagogastric junction adenocarcinoma (Sievert types I, II, III)
  • Measurable (RECIST criteria) or assessable disease
  • ECOG performance 0-2
  • Life expectancy of 12 weeks or more

Exclusion Criteria:

  • Immeasurable lesion as the only evidence of disease
  • Previous chemotherapy or radiotherapy for gastric neoplasm or some kind of previous surgical resection of the tumor (except diagnostic laparoscopy)
  • Concomitant heart disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130337

Locations
Spain
Elche, Alicante, Spain, 03203
Oviedo, Asturias, Spain, 33006
Santander, Cantabria, Spain, 39008
San Sebastian, Guipuzcoa, Spain, 20014
Palma de Mallorca, Islas Baleares, Spain, 07198
Vigo, Pontevedra, Spain, 36204
La Laguna, Tenerife, Spain, 38320
Barakaldo, Vizcaya, Spain, 48903
Barcelona, Spain, 08035
Barcelona, Spain, 08916
Barcelona, Spain, 08907
Barcelona, Spain, 08003
Barcelona, Spain, 08036
Burgos, Spain, 09006
Cordoba, Spain, 14004
Granada, Spain, 18014
La Coruña, Spain, 15006
Leon, Spain, 24071
Lerida, Spain, 25198
Lugo, Spain, 27003
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28007
Orense, Spain, 32005
Sevilla, Spain, 41014
Sevilla, Spain, 41013
Toledo, Spain, 45004
Valencia, Spain, 46009
Valencia, Spain, 46014
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01130337     History of Changes
Other Study ID Numbers: ML25189
Study First Received: May 25, 2010
Last Updated: August 26, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014