metastasized colorectal cancer MedDRA version: 8.1 Level: LLT Classification code 10052358 Term: Colorectal cancer metastatic
Conditions
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed written informed consents • Inpatient or outpatient =18 years of age • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum • 1st occurrence of metastatic disease (not curatively resectable) • EGFR-negative tumour • Life expectancy of at least 12 weeks • Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area) • ECOG performance status of = 2 at study entry • Effective contraception for both male and female subjects if the risk of conception exists • White blood cell count (WBC) = 3x10^9/L with neutrophils = 1.5x109/L, platelet count = 100x10^9/L, hemoglobin = 6.21 mmol/L (10 g/dL) • ASAT and ALAT = 2.5 x upper reference range, or = 5 x upper reference range in case of liver metastasis • Serum creatinine = 1.5 x upper reference range • Recovery from relevant toxicity to previous treatment before study entry 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: • Previous exposure to epidermal growth factor receptor-targeting therapy • Previous oxaliplatin-based chemotherapy • Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment • Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before inclusion. • Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol except physiologic replacement • Known hypersensitivity reaction to any of the components of study treatments • Pregnancy (absence to be confirmed by ß-hCG test) or lactation period • Brain metastasis and/or leptomeningeal disease (known or suspected) • Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease • Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix • Known alcohol or drug abuse • Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent • Participation in another clinical study within the 30 days before registration. • Significant disease which, in the investigator’s opinion, would exclude the subject from the study • Peripheral neuropathy > grade 1 • Legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rate of best confirmed response of 5-FU/FA plus oxaliplatin plus cetuximab as first-line treatment for undetectable epidermal growth factor in metastatic colorectal cancer.;Secondary Objective: • Curative metastatic surgery • Duration of response • Disease control rate • Progression-free survival time • Overall survival time • Safety;Primary end point(s): The primary target variable related to efficacy is the best overall confirmed tumor response to therapy of either CR or PR . Secondary target variables related to efficacy comprise variables based on tumor response and survival time. The following variables describe those, which are directly related to tumor response: • The duration of response to assess the time from first assessment of CR or PR until the first date of PD or death • Disease control on therapy, i.e. best overall response is either CR, PR, SD, provided the confirmation criteria are met (see section 7.2.3) • Progression-free survival time of a patient being defined as the time in months from start of treatment until PD is observed or death occurs due to any cause within 90 days after the last tumor assessment. In addition, survival time and curative metastatic surgery will be of further interest. | — |
Countries
Austria, Germany
Outcome results
None listed