None listed
Conditions
Interventions
AGC PATIENTS TREATED WITH DOSAGE SYSTEM APPROVED TRASTUZUMAB (LOADING DOSE 8 mg/kg FOLLOWED BY 6 mg/kg EVERY 3 WEEKS) IN THE PREVIOUS STUDY HAD BO1825/ToGA PHASE III VALUES OF TRASTUZUMAB Cmin <12 µg/
12 mcg/mL IN AFTER 2 CYCLES AND TREATMENT IN PATIENTS RANDOMIZED ALL, AS WELL AS IN THOSE PATIENTS WHOSE VALUES OF TRASTUZUMAB Cmin IN TREATMENT CYCLE 1 WERE <12 mcg/mL, and IF MORE EXPOSURE IS ALLOWA
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: GENERAL INCLUSION CRITERIA 1. MALE OR FEMALE. AGE ≥ 18 YEARS. 2. SIGNED INFORMED CONSENT. 3. ABILITY TO COMPLY WITH THE PROTOCOL. DISEASE SPECIFIC INCLUSION CRITERIA 4. HISTOLOGICALLY CONFIRMED ADENOCARCINOMA OF THE STOMACH OR GASTRO-ESOPHAGEAL JUNCTION WITH METASTATIC DISEASE DOCUMENTED TO INVOLVE AT LEAST TWO ORGANS (AT LEAST LIVER OR LUNG OR BOTH). 5. MEASURABLE DISEASE, ACCORDING TO THE RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST 1.1), ASSESSED USING IMAGING TECHNIQUES (COMPUTED TOMOGRAPHY [CT] OR MGNETIC RESONANCE IMAGING [MRI]), OR NON-MEASURABLE EVALUABLE DISEASE. 6. AT LEAST 2 ORGANS INVOLVED BY METASTATIC GASTRIC TUMOR (INCLUDING AT LEAST LUNG OR LIVER OR BOTH). 7. HER2-POSITIVE (DEFINED AS EITHER IHC 3+ OR IHC 2+/ISH+; WITH ISH-POSITIVITY DEFINED AS A RATIO OF ≥ 2.0 OF HER2 GENE COPY NUMBER/NUMBER OF SIGNALS FOR CEP17) PRIMARY OR METASTATIC TUMOR, AS ASSESSED BY THE CENTRAL LABORATORY. 8. CREATININE CLEARANCE (CrCI) ≥ 45 mL/min. 9. ECOG PERFORMANCE STATUS 2. I0. LIFE EXPECTANCY OF AT LEAST 3 MONTHS.
Exclusion criteria
Exclusion criteria: CANCER-RELATED EXCLUSION CRITERIA 1. PREVIOUS CHEMOTHERAPY FOR LOCALLY ADVANCED OR METASTATIC DISEASE (PRIOR CHEMOTHERAPY, IF NOT GIVEN FOR ADVANCED DISEASE, IS ALLOWED IF AT LEAST 6 MONTHS HAVE ELAPSED BETWEEN COMPLETION OF SUCH AND ENROLLMENT INTO THE STUDY). 2. PRIOR GASTRECTOMY (PARTIAL OR TOTAL) FOR THE UNDERLYING MALIGNANT DISEASE UNDER INVESTIGATION. 3. PRIOR THERAPY WITH AN ANTI-HER2 AGENT AND/OR A PLATINUM-BASED CHEMOTHERAPEUTIC AGENT. 4. LACK OF PHYSICAL INTEGRITY OF THE UPPER GASTROINTESTINAL TRACT OR MALABSORPTION SYNDROME (eg. PATIENTS WITH A JEJUNOSTOMY PROBE, GASTRIC OR JEJUNOSTOMY TUBES). THIS IS BECAUSE CAPECITABINE IS AN ORALLY ADMINISTERED DRUG. 5. CURRENT (SIGNIFICANT OR UNCONTROLLED) GASTROINTESTINAL BLEEDING. 6. RESIDUAL RELEVANT TOXICITY RESULTING FROM PREVIOUS THERAPY (WITH THE EXCEPTION OF ALOPECIA), eg. HEMATOLOGICAL OR NEUROLOGICAL TOXICITY ≥ GRADE 2 (NCI-CTCAE), EXCEPT STABLE NEUROLOGICAL DEFICIT DUE TO TREATMENT OCCURRING ≥ 5 YEARS EARLIER. 7. OTHER MALIGNANCY WITHIN THE LAST 5 YEARS, EXCEPT FOR CARCINOMA IN SITU OF THE CERVIX OR SQUAMOUS CELL CARCINOMA OF THE SKIN. HEMATOLOGICAL, BIOCHEMICAL AND ORGAN FUNCTION (WITHIN 7 DAYS PRIOR TO TREATMENT START 8. ABSOLUTE NEUTROPHIL COUNT (ANC) <1.5 x 10.9/L, OR PLATELET COUNT <100 x 10.9/L.
Countries
Australia, Bosnial and Herzegovina, Brazil, Chile, China, Czech Republic, Germany, Hungary, India, Italy, Korea South, Mexico, New Zealand, Panama, Philippines, Poland, Portugal, Russian Federation, South Africa, Spain, Turkey, Ukraine, United Kindgdom, United States, Yugoslavia
Outcome results
None listed