Unresectable locally advanced or metastatic Gastric Cancer MedDRA version: 20.0 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Campto
Pharmaceutical Form: Infusion
CAS Number: 136572-09-3
Other descriptive name: IRINOTECAN HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Co
Sponsors
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Signed informed consent •Histologically proven gastric adenocarcinoma •Measurable or evaluable, inoperable locally advanced or metastatic disease •No previous palliative chemotherapy and/or immunotherapy •Life expectancy of more than 3 months •Age = 18 years. •ECOG performance status 0 – 2 •Ability to understand and comply with requirements of study protocol and trial participation •Patients of either sex are eligible for study entry. Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception (e.g. intrauterine device (IUD), birth control pills, or barrier device) beginning 2 weeks prior to first dose of study drug until 6 months after the final dose of study drug. •Hematological status: Leucocytes = 3 x 109/l Platelets = 100 x 109/l •Renal function: Serum creatinine: = 1.5 x upper normal limit of normal (ULN) •Hepatic function: AST and ALT: =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: •Pregnant or lactating women. •Women of child-bearing potential and men not using effective contraception. •Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or •Neo/Adjuvant treatment with Bevacizumab •Patients with locally advanced disease who are candidates for curative therapy (including operation and/or chemotherapy and/or radiotherapy). •Prior history of chronic enteropathy, chronic diarrhea, unresolved bowel obstruction/ subobstruction, or extensive abdominopelvic radiation therapy. •Previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix. •Evidence of CNS metastasis at baseline. A CT or MRI scan within 28 days prior to randomisation is mandatory to exclude CNS involvement in case of clinical suspicion of CNS metastasis. •Peripheral neuropathy (NCI CTC grade = 1). •Inadequate renal function: •adequate renal function:ould be = 60 mL/min. The Cockroft and Gault formula is recommended for calculation of creatinine clearance. Patients with a creatinine clearance just below 60 ml/min may be eligible if a measured creatinine clearance (based on 24 hour urine collection or other reliable method) is = 60 mL/min. • Urine dipstick for proteinuria should be 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (= 6 months prior to randomisation), myocardial infarction (= 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment. •Prior history of hypertensive crisis or hypertensive encephalopathy. •Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava). •Serious uncontrolled coagulation disorder or thrombo-embolic complications (history of embolisms or thromboses) within 6 months prior to study start or history of inherited bleeding diathesis or coagulopathy with the risk of bleeding. •Major surgical procedures within 4 weeks prior to study entry or planned major surgical procedures throughout the course of the study. Patients must have fully recovered from any surgical procedures conducted prior to 4 weeks before study entry. •Minor surgery, including insertion of an indwelling catheter, within 48 hours prior to the first bevacizumab infusion. •Concurrent or recent (within 10 days) anticoagulant therapy. Prophylactic use of anticoagulants is allowed. •Chronic daily treatment with aspirin (> 325 mg/da
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the efficacy of an Oxaliplatin / Irinotecan / Bevacizumab therapy followed by Docetaxel / Bevacizumab therapy followed by Bevacizumab until progression in the treatment of locally advanced metastatic gastric cancer, in terms of response rates (complete or partial response, determined by radiologic evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST)).;Secondary Objective: •To determine the safety profile of a an Oxaliplatin / Irinotecan / Bevacizumab therapy followed by Docetaxel / Bevacizumab therapy followed by Bevacizumab until progression in terms of qualitative and quantitative toxicities from first study treatment dose until completion of study treatment due to pro gression or for any other reason. •To evaluate the study population with respect to the following: overall survival (from treatment start until death from any cause) and progression free survival (from treatment start until progression or death from any cause). ;Primary end point(s): Efficacy (Response Rate) ;Timepoint(s) of evaluation of this end point: Staging (including imaging) shall be done at 12-weekly intervals (i.e. every third cycle) until documented progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Qualitative and quantitative toxicities;Timepoint(s) of evaluation of this end point: Safety assessments shall be conducted at 4-weekly intervals (i.e. every cycle) until progression. | — |
Countries
Austria
Contacts
Public ContactDaniela Wolkersdorfer
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Outcome results
None listed