Cáncer colorrectal metastásico Metastatic Colorectal Cancer MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Interventions
Product Name: IMC-1121B
Product Code: IMC-1121B
Pharmaceutical Form: Solution for infusion
CAS Number: 947 687-13-0
Current Sponsor code: IMC-1121B
Other descriptive name: Recombinant Human IgG1 Monoc
Sponsors
ImClone Systems Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient must have histologically-confirmed adenocarcinoma of the colon or rectum that is locally-advanced or metastatic und unresectable. The patient has at least one unidimensionally-measurable target lesion (= 2 cm with conventional techniques or = 1 cm with spiral computed tomography [CT] scan or magnetic resonance imaging [MRI], as defined by Response Evaluation Criteria in Solid Tumors [RECIST], see Section 11); target lesion(s) must not lie within an irradiated area.. Patients with locally advanced rectal carcinoma who have undergone previous radiation must have documented evidence of disease progression in the pelvis in order to participate. The patient is age = 18 years. The patient has a life expectancy of = 6 months. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry. The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) = 1500/µL, hemoglobin = 10g/dL, and platelets =100,000/µL. The patient has adequate hepatic function as defined by: total bilirubin = 1.5 x upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) = 3.0 x ULN [or 5.0 x ULN in the case of liver metastases], and serum albumin = lower limit of normal institutional range (LLN) or (if =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The patient has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC. Prior adjuvant chemotherapy is allowed if disease progression has been documented > 6 months after the end of the last cycle of adjuvant chemotherapy or > 12 months after the end of the last cycle of adjuvant oxaliplatin-containing regimens. The patient has documented and/or symptomatic brain or leptomeningeal metastases. The patient has participated in clinical studies of nonapproved experimental agents or procedures within 12 weeks of study entry. The patient has received previous therapy with monoclonal antibodies. The patient has received previous therapy with any agent that targets VEGF or VEGFR-2 (including multi-targeted tyrosine kinase inhibitors). The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator. The patient is on chronic nontopical corticosteroid treatment for > 6 months at doses > 10 mg/day of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the patient or the study. The patient has a known dihydropyrimidine dehydrogenase (DPD) deficiency. The patient has a known allergy to any of the treatment components. The patient has an acute or subacute intestinal obstruction. The patient has uncontrolled or poorly controlled hypertension on a standard regimen of anti-hypertensive therapy. The patient has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years. The patient, if female, is pregnant (confirmed by serum beta human chorionic gonadotropin [ßHCG] test) or lactating. The patient has received a prior autologus or allogeneic organ or tissue transplantation. The patient has interstitial pneumonia or interstitial fibrosis of the lung, which in the opinion of the investigator could compromise the patient or the study. The patient has pleural effusion or ascites that causes >Grade 1 dyspnea. The patient has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent. The patient has undergone major surgery within 28 days prior to the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this study are to evaluate: -Objective response rate (ORR) -Overall survival (OS) -Duration of response -Safety profile -Pharmacokinetic (PK) profile and immunogenicity of IMC-1121B.;Main Objective: The primary objective of this study is to evaluate the progression-free survival (PFS) in patients with metastatic colorectal cancer when treated with the monoclonal antibody IMC-1121B in combination with the modified FOLFOX-6 (folinic acid [FA] + fluorouracil [5-FU] + oxaliplatin, mFOLFOX-6) chemotherapy regimen as first-line therapy.;Primary end point(s): Primary Efficacy Endpoint -Progression-free Survival: PFS is defined as the time from the first day of therapy to the first evidence of progression as defined by RECIST, or death from any cause, whichever is first. Patients who die without a reported prior progression or have missed two or more scheduled visits will be censored at the date of the last radiographic assessment. Patients alive and without disease progression will be censored at the time of the last objective tumor assessment. Patients who do not progress and are subsequently lost to follow-up will have their data censored at the day of their last objective tumor assessment. | — |
Countries
Spain
Outcome results
None listed