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A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer (TOXAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01748773
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer. Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin 100 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25 doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time on study treatment is 1 year plus a 1-year follow-up period.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Cancer Drug: Oxaliplatin Radiation: Radiation Drug: Capecitabine Drug: Trastuzumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Operated Patients With HER-2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma: Phase II Study, TOXAG [ML25574]
Actual Study Start Date : January 29, 2013
Actual Primary Completion Date : August 21, 2015
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
 Drug: Oxaliplatin
Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3.

Radiation: Radiation
Participants will receive radiotherapy at total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 1 of Cycle 4.

Drug: Capecitabine
Participants will receive capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.

Drug: Trastuzumab
Participants will receive trastuzumab 8 mg/kg IV on Day 1 Cycle 1, 6 mg/kg IV on Day 1 of each following 3-week cycle for 12 months (a total of 17 doses).


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 13 ]
  2. Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score [ Time Frame: From Baseline to Month 13 ]

Secondary Outcome Measures :
  1. Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months) ]
  2. Overall Survival [ Time Frame: Cycle 1 Day 1 up to death due to any reason (up to 24 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Curatively resected HER2+ gastric or gastroesophageal junction adenocarcinoma; HER2+ status as defined by immunohistochemistry-2 positive or 3 positive with corroborative Fluorescence In Situ Hybridization+ result
  • Participants with stages between Stage IB (T1N1M0) and Stage IIIC
  • ECOG performance status score equal to or less than (<=) 2 during screening
  • Left ventricular ejection fraction equal to or higher than (>=) 55% with acceptable levels of liver and renal functions
  • No known contraindication to capecitabine, oxaliplatin, and trastuzumab
  • No contraindication for radiotherapy or has not received any previous radiotherapy to the gastric region for any reason

Exclusion Criteria:

  • Participants with a malign condition in the last 5 years except squamous cell carcinoma of the skin
  • Previous neoadjuvant chemotherapy and/or radiotherapy
  • Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastroesophageal junction carcinoma)
  • Known (previously diagnosed and ongoing) malabsorption syndrome
  • Active gastrointestinal bleeding
  • Participants with Stage IV gastric or gastroesophageal junction adenocarcinoma
  • Clinically significant cardiac or cardiovascular disease
  • Uncontrolled hypertension
  • Participants who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study
  • Abnormal laboratory values at screening for serum total bilirubin, alanine aminotransferase or aspartate amino transferase, alkaline phosphatase, absolute neutrophil count, platelet count, and/or hemoglobin
  • Known or suspected hypersensitivity against trastuzumab or proteins of rodents
  • Pregnancy or lactation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748773


Locations
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Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey, 01250
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara, Turkey, 06100
Ankara Oncology Hospital; Oncology
Ankara, Turkey, 06200
Baskent University Medical Faculty; Internal Medicine
Ankara, Turkey, 06490
Gaziantep University Medical Faculty, Medical Oncology Department
Gaziantep, Turkey, 27310
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, Turkey, 34890
Ege Uni Medical Faculty; Oncology Dept
Izmir, Turkey, 35100
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
Konya, Turkey, 42080
Bilkent Sehir Hospita; ONKOLOJI
Çankaya/Ankara, Turkey, 06800
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01748773    
Other Study ID Numbers: ML25574
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Capecitabine
Oxaliplatin
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological