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

Gastric Cancer Clinical Trial

— TOXAG  

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748773
• Other study ID #: ML25574
• Status: Completed
• Phase: Phase 2
• Start date: January 29, 2013
• Est. completion date: June 15, 2017

Study information

• Verified date: October 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 15, 2017
• Est. primary completion date: August 21, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastroesophageal Junction Cancer
• Stomach Neoplasms

Intervention

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.
• 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).

Locations

Country	Name	City	State
Turkey	Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology	Adana
Turkey	Ankara Oncology Hospital; Oncology	Ankara
Turkey	Baskent University Medical Faculty; Internal Medicine	Ankara
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Ankara
Turkey	Bilkent Sehir Hospita; ONKOLOJI	Çankaya/Ankara
Turkey	Gaziantep University Medical Faculty, Medical Oncology Department	Gaziantep
Turkey	Marmara Uni Faculty of Medicine; Medical Oncology	Istanbul
Turkey	Ege Uni Medical Faculty; Oncology Dept	Izmir
Turkey	Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Baseline up to Month 13
Primary	Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score		From Baseline to Month 13
Secondary	Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST)		Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months)
Secondary	Overall Survival		Cycle 1 Day 1 up to death due to any reason (up to 24 months)