None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Lapatinib 1000 mg PO once a day until the progression of the disease, treatment of emerging toxicities, maximum response or withdrawal of the consent.
Group name:GROUP 2 Type of group
This group will be treated with Lapatinib 1500 mg PO once a day until the progression of the disease, treatment of emerging toxicities, maximum response or withdrawal of the consen
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients may have had 1 or 2 previous chemotherapy regimens for mestastatic or recurrent disease. 2. Patients have adenocarcinoma of the esophagus, GE junction or histologically confirmed gastric cardia, which a) express ErbBl and / or overexpress ErbB2 by IHC (2 and 3+) or demonstrate amplification of the ErbB2 gene by FISH, and b) if a biopsy can be easily performed. 3. Patients are at least 18 years of age. 4. A woman is eligible to enter and participate in the study if: a) She has no potential to have children. b) Had a hysterectomy. c) Had a bilateral oophorectomy. d) had already had a bilateral tubal ligation. e) It is post-menopausal. 5. Has the potential to have children, has a negative serum pregnancy test in the Selection and agrees to use an acceptable method of contraception. 6. BCOG Performance Status 9 g / dL (5 nmol / L). 10. Absolute granulocyte count> 1,500 / mm3 (1.5 x 10-9 / L).
Exclusion criteria
Exclusion criteria: 1. Pregnant woman or breastfeeding. 2. Previous small bowel resection. 3. The Investigator considers that the patient is not in medical condition for the study. 4. Presents a clinically significant abnormality on the ECG. 5. The patient is taking any medication found in the list of prohibited medications. 6. The patient has a history of allergy to the drug or to others, which, in the opinion of the Investigator, contraindicates their participation. 7. The patient has a known reaction of immediate or delayed hypersensitivity or idiosyncrasy to drugs chemically related to the study drug. 8. The patient received treatment with an investigational drug in the previous four weeks. 9. The patient was treated with any biological, cytotoxic, hormonal or radiation therapy therapy within the previous four weeks. 10. Major surgery within the previous two weeks. 11. Aspartate or alanine transaminase (ALT or AST) greater than three times the upper limit of the reference range (ULRR). 12. Physiological, family, sociological or geographic conditions that do not allow compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Imaging according to clinical criteria and availability: Chest x-ray, CT, MRI, FDG-PET. Measure:Primary efficacy: Objective response rate (ORR), based on the complete response (CR) and on the partial response (PR) according to the RECIST criteria. Timepoints:Clinical evaluation: Days 0, 21 and monthly from this point until the treatment ends. Imaging: At the beginning of the treatment and on day 20. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Imaging according to clinical criteria and availability: Chest x-ray, CT, MRI, FDG-PET. Measure:Secondary Efficacy: Tumor response or stabilization of the disease (Percentage of subjects reaching CR or PR). Survival free of illness or death due to any cause. Duration of the response (Time from CR or PR until the first sign of disease progression or death due to cancer). Timepoints:Clinical evaluation: Days 0, 21 and monthly from this point until the treatment ends. Imaging: At the beginning of the treatment and on day 20. ; Outcome name:Clinical laboratory: Complete blood count, Na, K, Ca, total protein, albumin, GGT, total bilirubin, alkaline phosphatase, LDH, AST, ALT, creatinine, BUN, Beta HCG serum. Clinical examination. 12-lead ECG. MUGA / Echocardiography. Measure:Safety of treatment: Laboratory tests. Monitoring of adverse events. Cardiac toxicity. Timepoints:Clinical laboratory: At the beginning of treatment and monthly after the first 21 days of therapy. Clinical examination: Days 0, 21 and monthly from this point until the treatment ends. Imaging: At the beginning of the treatment and on day 20. 12-lead ECG: At the start of treatment. MUGA / Echocardiography: At the beginning of treatment and monthly after the first 21 days of therapy. ; Outcome name:Two blood samples of 5 mL, taken before the dose and during the monthly visits: Proteomic analysis and determine the changes in circulating / secreted proteins (serum ECD). Tumor sample: Determination of the phosphorylation of ErbBl and / or ErbB2, in addition to the biomarkers of cell proliferation ErbBl, ErbB2, p-ErbBl, ErbB3, TUNEL, IGFIR, and others in potency, such as HGF, GRP and CCR2). Measure:Pharmacodynamics Timepoints:Day 21 of treatment and monthly from this point until the completion of therapy. ; Outcome name:Peripheral blood samples of 10 ml in the first 21 days and 2 ml monthly in the f | — |
Countries
Netherlands, Peru, United States
Outcome results
None listed