Estudio de fase 2, multicéntrico, en abierto, para evaluar la seguridad y la eficacia del IMC-1121B en combinación con 5-FU/AF y oxaliplatino (FOLFOX-6 modificado) como tratamiento de primera línea en pacientes con cáncer colorrectal metastásico.An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B in Combination with 5-FU/FA and Oxaliplatin (Modified FOLFOX-6) as First-line Therapy in Patients with Metastatic Colorectal Cancer.
- Conditions
- Cáncer colorrectal metastásicoMetastatic Colorectal CancerMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer
- Registration Number
- EUCTR2008-004936-19-ES
- Lead Sponsor
- ImClone Systems Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
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 < LLN) within 10% of the LLN.
The patient has adequate renal function as defined by a serum creatinine = 1.5 x ULN, or creatinine clearance (measured via 24-hour urine collection) = 60 mL/min.
The patient's urinary protein = 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine urinalysis is = 2+, a 24 hour urine for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study).
The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 5 seconds above the ULN. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight (LMW) heparin and if on warfarin, must have an INR between 2 and 3 and no active bleeding or pathological condition present that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
The patient has resolution to Grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to Grade 0.
The patient agrees to use adequate contraception during the study period and for 8 weeks after the last dose of study treatment.
The patient has provided signed informed consent.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method