E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
first-line therapy in patients with metastatic colorectal cancer |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of FOLFOX6 plus cetuximab and FOLFIRI plus cetuximab with respect to the percentage of patients surviving without disease progression as assessed by RECIST criteria in each arm at 9 months
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of these combination therapies with respect to the objective response rates as assessed by RECIST criteria, the percentages of patients surviving without disease progression in each arm at 3, 6 and 12 months, and the overall survival in each arm.
To evaluate the safety profile of these combinations by recording the adverse events and abnormal laboratory values associated with the study treatments.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•Signed written informed consent •Male or female more or equal 18 years of age •Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum •Metastatic colorectal carcinoma not suitable for curative-intent resection •Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment •Presence of at least one lesion measurable unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area) •ECOG performance status less than 2 •White blood cell count more or equal 3.0 x 109/L with neutrophils more or equal 1.5 x 109/L, platelet count more or equal 100 x 109/L, and hemoglobin more or equal 9 g/dL. •Bilirubin level either normal or less or equal 1.5 x ULN •ASAT and ALAT less or equal 2.5 x ULN (less or equal 5 x ULN if liver metastasis are present) •Serum creatinine less or equal 1.5 x ULN
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E.4 | Principal exclusion criteria |
•Brain metastasis (known or suspected) •Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months. •Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol •Any investigational agent(s) within 4 weeks prior to entry •Previous exposure to EGFR-pathway targeting therapy •Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months •Acute or subacute intestinal occlusion or history of inflammatory bowel disease •Pre-existing neuropathy > grade 1 •Known grade 3 or 4 allergic reaction to any of the components of the treatment. •Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for more or equal 5 years will be allowed to enter the trial) •Pregnancy or lactation •Inadequate contraception (male or female patients) if of childbearing or procreational potential •Known drug abuse/ alcohol abuse •Legal incapacity or limited legal capacity •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of patients in each arm surviving without disease progression at 9 months as assessed by RECIST criteria
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |