Chemorefractory metastatic adenocarcinoma of stomach, esophagogastric junction and lower esophagus (Barrett carcinoma) MedDRA version: 8.1 Level: LLT Classification code 10017758 Term: Gastric cancer
Conditions
Interventions
Trade Name: SUTENT
Product Name: Sunitinib, Sutent
Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib-Malat
CAS Number: 341031-54-7
Current Sponsor
Sponsors
Johannes-Gutenberg-Universität Mainz, I. Medizinische Klinik und Poliklinik
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged 18 years and older 2.Signed and dated informed consent of the patient before the start of specific protocol procedures 3.Histologically proven adenocarcinoma of stomach, esophagogastric junction or lower esophagus (Barrett carcinoma) 4.Measurable metastatic disease according to the RECIST (33). If locally recurrent disease, it must be associated with at least one measurable lymph node (> 20 mm by CT scan or > 10 mm with spiral CT) 5.Failure of prior palliative chemotherapy/chemotherapies (at least one Irinotecan- or Cisplatin-based). Failure is defined either by progression of disease or by significant toxicity that precludes further treatment 6.At least 3 weeks from previous chemotherapy at first dose of study drug 7.Resolution of all acute toxic side effects of prior therapy or surgical procedures to grade = 1 NCI-CTC criteria (except for the laboratory values) 8.Adequate organ function as defined by the following criteria: •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ?2.5 x upper limit of normal (ULN), or AST and ALT ?5 x ULN if liver function abnormalities are due to underlying malignancy •Total serum bilirubin ?1.5 x ULN •Absolute neutrophil count (ANC) ?1500/?L •Platelets ?100,000/?L •Hemoglobin ?8.0 g/dL without support of growth factors (previous administration of erythrocyte concentrate is allowed) •Serum calcium ?12.0 mg/dL •Serum creatinine ?2.0 x ULN •Lipase/Amylase = 2,5 x ULN •All other laboratory values specified in chaper 7.6: resolution of all side effects of prior therapy or surgical procedure to grade 12 weeks 12.Patients must be able to swallow SUNITINIB capsules 13.Patients who understand the nature of the trial and are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures 14.Female patients who are capable of bearing children must have a negative pregnancy test result (serum or urine) at study entry. All women included in the study must be surgically sterile or postmenopausal or agree to employ adequate birth control measures for the duration of the study and six months post-dosing. Male patients must be surgically sterile or must agree to use effective contraception during the study and six months post-dosing (for details see chapter 7.7). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Other tumor type than adenocarcinoma (e.g., leiomyosarcoma, lymphoma) or a second cancer except in patients with squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix which has been effectively treated. Patients curatively treated and disease free for at least 5 years will be discussed with the sponsor before inclusion 2.Patients with known brain or leptomeningeal metastasis 3.Intake of non-permitted concomitant drugs (the coordinating investigator should be contacted to discuss the individual case), see chapter 5.4: •Concomitant treatment with antiarrhythmics and drugs with dysrhythmic potential (ie, terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide) •Administration of potent CYP34A inhibitors during or within 7 days before start of SUNITINIB-treatment (e.g. ketoconazole, itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, indinavir, saquinavir, ritonavir, atazanavir, nelfinavir, grapefruitjuice) •Administration of potent CYP3A4 inducers during or within 12 days before start of SUNITINIB-treatment (e.g. dexamethason, rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John´s wort, efavirenz, tipranavir •Ongoing treatment with therapeutic doses of anticoagulants such as Coumadin or heparins (however, low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed) •Any other medicinal anticancer therapy during treatment phase except treatment with non-conventional therapies (e.g. herbs or acupuncture) and vitamins/mineral supplements, provided that they do not interfere with the study endpoint, in the opinion of the investigator •Concurrent systemic immune therapy, chemo- or hormone therapy •Concomitant or within a 4-week period administration (from first dose of study drug) of any other experimental drug under investigation (except of Irinotecan and Cetuximab) and participation in another clinical trial 4.Any prior radiotherapy of target lesions 5.Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis 6.Current history of chronic diarrhoea 7.Active disseminated intravascular coagulation, or patients prone to thromboembolism 8.Any of the following events (in any grade) prior to starting the trial treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism 9.Known history of QT interval prolongation, ongoing QT prolongation (>450 msec for males or >470 msec for females), any cardiac ventricular dysrhythmias, atrial fibrillation of any grade 10.Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy) 11.Known human immunodeficiency virus (HIV) infection 12.Active uncontrolled infection 13.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial 14.Pregnant or lactating women 15.Known allergic/hypersensitivity reaction to any of the components of the treatme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the antitumor activity of SUNITINIB administered as a single agent in patients with metastatic gastric cancer refractory to cisplatin- and/or irinotecan-based chemotherapy;Secondary Objective: The secondary objectives are: - Effects of SUNITINIB on the time to tumor progression and - effects of SUNITINIB on survival (one-year survival and overall survival) - Safety and tolerability of SUNITINIB;Primary end point(s): The primary endpoint is the objective response rate within the first six treatment cycles defined as the percentage of patients with a confirmed reduction in tumor size compared to baseline fulfilling the criteria for complete or partial response as defined in chapter 7.8. The response is measured by CT. | — |
Countries
Germany
Outcome results
None listed