None listed
Conditions
Interventions
Group 1 Type of group
Lapatinib 5 tablets at 250 mg each once a day + Capecitabine 1700 mg / m2 / day in two daily doses + Oxaliplatin 130 mg / m2 on day 1 of each cycle for a maximum of 8 cycles. Oxaliplatin should be administered intravenously in 500 mL of D5W for 2 hours.
Group name:Group 2 Type of group
Placebo of Lapatinib 5 tablets at 250 mg each once a day + Capecitabine 1700 mg / m2 / day in two daily doses + Oxaliplatin 130 mg / m2 on day 1 of each cycle for a maximum of 8 cycles. Oxaliplatin should be administered intravenously in 500 mL of D5W for 2 hours.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Signed informed consent; have the will and be able to complete all the required components of the study. • Histologically confirmed gastric adenocarcinoma, adenocarcinoma of the esophagus or gastroesophageal junction. Pathologic confirmation of the area of ​​metastasis should be performed. The practice of primary tumor biopsy is not necessary. Subjects with pathological confirmation of a metastatic area along with clinical / radiological documentation of gastric implication and no evidence of other primary tumors will also be eligible. • Locally advanced non-operable gastric cancer (defined as stage IV: T4N1-3 or TanyN3), metastatic (defined as stage IV: TanyNanyMl) or locally recurrent. Esophageal cancer that is locally advanced and non-operable (T3N1 or T4Nany), metastatic (MI) or locally recurrent. {NdeT: Tany = any stage of the Tumor; Nany — any stage of the node). • Measurable or non-measurable but radiologically evaluable disease, according to RECIST [Therasse, 2000]. X-rays, imaging studies, or physical exams for both types of illness (measurable or non-measurable) must be completed within 28 days prior to registration. • Positive ErbB2 status evaluated by local laboratory (IHC 3+ or FISH positive or CISH positive). ErbB2 status can be assessed from the primary or metastatic tumor. Subjects with unknown ErbB2 status will not be eligible. All subjects should be provided with tumor tissue upon admission to the study and sent to the central laboratory to determine the centralized state of ErbB2. • Age greater than or equal to 18 years. • General status of ECOG 2 • Evaluation of appropriate organic functions within 14 days prior to random distribution. Hematological function: RAN L5xl0 / L, Hemoglobin 9g / dL (with support transfusion, if required), Platelets 100 x 10 / L. Liver function: Total bilirubin 1.5 x UNL (or 2.5 x UNL in case of documented Gilberts syndrome), AST / ALT 3 x UNL (or 5 x UNL in case of documented liver metastasis). Renal function: Serum creatinine 2.0 mg / dL and Creatinine Clearance Calculation 50 mL / min (Cockcroft-Gault method) • Cardiac ejection fraction within the normal institutional range as determined by echocardiograms. MUGA studies will be accepted if an echocardiogram cannot be performed or is inconclusive. • Ability to ingest and retain oral medication, and / or receive enteral medication through a feeding tube (gastrectomy) (Non-NPO subjects will be considered eligible only after analysis of the study´s medical monitor). • Potentially fertile male and female subjects should agree to practice birth control methods during the study. • Previous / concurrent therapy.
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding women at any time during the study. • Known history of active CNS disease. • Uncontrolled ascites • Concurrent cancer therapies (chemotherapy, radiation therapy, in addition to pain relief therapies, immunotherapy, biological, hormonal therapy or surgery) during the treatment under investigation. • Gastric carcinoid, epidermoid, sarcomas or squamous cell carcinoma. • Previous palliative chemotherapy for the treatment of gastric cancer. • Previous treatment with oxaliplatin or CapeOx regimen • Malabsorption syndrome or uncontrolled gastrointestinal inflammatory disease (such as Crohn´s disease or ulcerative colitis). • Known history of symptomatic or uncontrolled angina, arrhythmias or congestive heart failure. • Sensory or motor neuropathy grade 2 pre-existing by CTC v3.0. • Uncontrolled infection. • Concurrent illness or condition that could make the subject inappropriate to participate in the study, or any serious medical condition that could interfere with the subject´s safety. • History of other malignant tumors except for: Subjects who have not been ill for 5 years, Subjects with a history of fully operable nonmelanoma skin cancer, Subjects with successful treatment of carcinoma in situ. • Severe unresolved or unstable toxicity from previous administration of other investigational drugs and / or previous cancer treatments. • Dementia, state of mental disorder or any psychiatric condition that could prohibit the understanding or granting of informed consent. • Known history of DPD deficiencies. • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platinum or their excipients. • The use of any investigational medication within 30 days prior to random distribution. • The use of prohibited concurrent medications that could interact with the medications under study, including herbal remedies, traditional Chinese medicines for the treatment of cancer and any other medication or drugs detailed in Table 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Measure:Overall Survival Timepoints:From randomization until death due to any cause (average of 51 weeks) ; Outcome name:Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Measure:Overall Survival in All Randomized Participants Timepoints:From randomization until death due to any cause (average of 51 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:PFS is defined as the interval between the date of randomization and the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >= 1 new lesion. Participants who did not have a radiological assessed PD but had symptomatic PD were also counted. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored. Measure:Progression Free Survival (PFS) Timepoints:From randomization until the earliest date of disease progression or death due to any cause (average of 30 weeks) ; Outcome name:A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target and non-target lesions) or a PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) as assessed by the investigator (confirmed by radiographic imaging within 4 weeks from initial observations). Measure:Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) Timepoints:From randomization until the date of the first documented response of CR or PR (average of 9 weeks) ; Outcome name:CB is defined as evidence of a CR (disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatme | — |
Countries
Argentina, Brazil, Canada, Chile, China, Estonia, Hungary, India, Israel, Italy, Korea South, Mexico, Netherlands, Peru, Poland, Puerto Rico, Russian Federation, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactSarita Mattos
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed