Metastatic colorectal cancer MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Sponsors
AIO Studien gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed written informed consent - Male or female >/= 18 years - Histologically proven metastatic colorectal cancer - Molecular testing showing KRAS wild type in colorectal carcinoma cells - Life expectancy > 12 weeks - At least one measurable lesion according to RECIST 1.1 - Adequate bone marrow, liver, kidney, organ and metabolic function - ECOG perfomance status 0-1 - Woman of child-bearing potential must have a negative pregnancy test 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: - Previous treatment for colorectal cancer in the metastatic setting with the exception that patients with urgent need of immediate treatment (high tumor load, symptoms) may have received one cycle of any FOLFOX regimen (no capecitabine!) in case of yet unconfirmed RAS status - Previous EGFR-targeting therapy -Complete or partial DPD-deficiency. DPD deficiency can be evaluated by measuring the uracil plasmalevel or by genotyping of the DPD-coding gene (DPYD). - /= NCI-CTC V 4.03 grade 2 - Other previous malignancies with the exception of a history of previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix or other curatively treated malignat disease without recurrance after at least 5 years of follow-up - Significant disease that, in the investigator´s opinion, would exclude the patient from the study - History of cardiac deseases, defined as: ° Congestive heart failure > New York Aheart Assiciation (NYHA) class 2 ° Active coronary artery disease (myocardial infarction more than 6 months prior to start of study treatment is allowed) ° Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted) ° Uncontrolled hypertension (defined as blood preasure >/= 160 mmHg systolic and/or >/= 90 mmHg diastolic on medication) - Patients with interstitial lung disease, e. g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan - Known HIV, hepatitis B or C infection - Known hypertensitivity reaction to any of the study components - Radiotherapy, major surgery or any investigational drug 21 days before registration - Pregnancy or lactation or planning to be pregnant during treatment and within 6 months after the end of treatment - Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for at least an additional 6 months after the end of treatment - Known alcohol or drug abuse - Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of panitumumab plus 5-FU/FA as maintenance after an induction treatment of 12 weeks with mFOLFOX6 plus panitumumab in the first-line treatment of KRAS wild type metastatic colorectal cancer patients compared to 5-FU/FA maintenance alone in terms of progression-free survival;Secondary Objective: To compare maintenance arms with respect to: - Time from randomization until failure of treatment strategy (death/progression) - Progression-free survival of re-induction - Objective response after 12 weeks of induction chemotherapy - Objective best response during maintenance and re-induction - Overall survival measured from time of randomization and from time of registration - Safety - Health and skin related Quality of life;Primary end point(s): Progession-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time from randomization until failure of treatment strategy (death/progression) - Progression-free survival of re-induction - Objective response after 12 weeks of induction chemotherapy - Objective best response during maintenance and re-induction - Overall survival measured from time of randomization and from time of registration - Safety - Health and skin related Quality of life | — |
Countries
Germany
Contacts
Public ContactDr. Martin Mänz
AIO-Studien-gGmbH
Outcome results
None listed