EUCTR2018-003778-29-IT
Active, not recruiting
Phase 1
Phase II study on the use of the FOLFIRI + Cetuximab association in the first-line treatment of patients with advanced colorectal carcinoma with wild type RAS and FcYRIIIA-V / V - CIFRA
Istituto Nazionale Tumori G. Pascale0 sites34 target enrollmentJanuary 14, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- advanced colorectal carcinoma with wild type RAS and FcyRIIIA-V / V
- Sponsor
- Istituto Nazionale Tumori G. Pascale
- Enrollment
- 34
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cytological or histological diagnosis of colorectal adenocarcinoma
- •wild\-type RAS
- •Fc?RIIIa\-158V / V genotype
- •Negative pregnancy test where applicable
- •Age \<75 years
- •At least 1 lesion measurable according to the RECIST criteria v1\.1
- •ECOG Performance Status 0 or 1
- •Life expectancy\> 3 months
- •Written informed consent
- •Are the trial subjects under 18? no
Exclusion Criteria
- •Previous systemic anti\-tumor treatment; allowed treatment with Capecitabine or fluorouraciol and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated for at least 6 months.
- •Presence of primary non\-treated stenosing colorectal neoplasm with endoprosthesis positioning
- •Neutrophils \<2000 / mm³ or platelets \<100,000 / mm³ or hemoglobin \<9 g / dl
- •Creatinineemia\> 1\.5 times the maximum normal value
- •GOT and / or GPT\> 5 times the maximum normal value and / or bilirubinemia\> 3 times the maximum normal value
- •Previous malignant neoplasm (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix)
- •Infection in active or uncontrolled phase
- •Other concomitant disorders that are decompensated or uncontrolled or that contraindicate the study drugs at the judgment of the clinician
- •Presence of brain metastases
- •Refusal or inability to provide informed consent
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.Colorectal CancerJPRN-UMIN000007372Kurume University School of medicine, Department of Surgery30
Completed
Phase 2
Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancerColorectal cancerJPRN-UMIN000023026Department of Clinical Oncology, St. Marianna University School of Medicine54
Completed
Phase 2
Phase IIstudy of biweekly FOLFIRI+cetuximab treatment for unresectable KRAS-wild type colorectal cancerunresectable colorectal cancerJPRN-UMIN000011363Dept of Surgical Oncology Osaka City University Graduate School of Medicine20
Completed
Phase 2
Phase II study of FOLFIRI+biweekly cetuximab for KRAS wild type unresectable colorectal cancer.unresectable colorectal cancerJPRN-UMIN000011364Osaka City University20
Completed
Phase 1
Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancerRAS wild-type unresectable colorectal cancerJPRN-UMIN000015620Aichi Cancer Center Hospital12