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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01130337
First received: May 25, 2010
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will evaluate the disease free survival rate of a combination of capecitabine [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patients 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 alone. 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: Trastuzumab [Herceptin]
Drug: Capecitabine [Xeloda]
Drug: Oxalipatin
 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:

U.S. FDA Resources

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
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Trastuzumab [Herceptin]
First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
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

  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
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
La Coruna, La Coruña, Spain, 15006
Vigo, Pontevedra, Spain, 36204
La Laguna, Tenerife, Spain, 38320
Barakaldo, Vizcaya, Spain, 48903
Barcelona, Spain, 08907
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08003
Barcelona, Spain, 08916
Burgos, Spain, 09005
Cordoba, Spain, 14004
Granada, Spain, 18014
Leon, Spain, 24071
Lerida, Spain, 25198
Lugo, Spain, 27003
Madrid, Spain, 28040
Madrid, Spain, 28041
Orense, Spain, 32005
Sevilla, Spain, 41013
Sevilla, Spain, 41014
Toledo, Spain, 45004
Valencia, Spain, 46014
Valencia, Spain, 46009
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: May 23, 2013
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 May 23, 2013