EUCTR2006-003147-23-BE进行中（未招募）不适用
OPEN LABEL, MULTICENTER, PHASE II STUDY EVALUATING THE EFFICACY AND SAFETY OF IMC-11F8 IN COMBINATION WITH 5-FU/FA AND OXALIPLATIN (MODIFIED FOLFOX-6) IN PATIENTS WITH TREATMENT-NAÏVE, LOCALLY-ADVANCED OR METASTATIC COLORECTAL CANCER - IMCL CP11-0602
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ImClone LLC
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.The patient must have histologically-confirmed, EGFR-detectable or EGFR-undetectable colorectal cancer. Patients who do not have tissue available for EGFR testing will undergo biopsy of an accessible tumor. A waiver may be given to patients who do not wish to undergo a biopsy.
- •2.The patient has locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum.
- •3.The patient has at least one unidimensionally-measurable target lesion (=2 cm with conventional techniques or =1 cm with spiral computed tomography [CT] scan) by CT scan or magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated area.
- •4.The patient is age =18 years.
- •5.The patient has a life expectancy of =6 months.
- •6.The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) <2 at study entry.
- •7.The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) =1.5 x 109/L, hemoglobin =10 g/dL (the patient may be transfused or may be receiving erythropoietin to meet this criterion), and platelets =100 x 109/L.
- •8.The patient has adequate hepatic function as defined by a total bilirubin =1.5 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 X upper limit of normal (ULN) [or 5.0 x ULN in the case of liver metastases], and alkaline phosphatase =2.5 x ULN (or 5.0 x ULN in the case of liver metastases).
- •9.The patient has adequate renal function as defined by a serum creatinine ? 1.5 x ULN, creatinine clearance (measured or calculated) =60 mL/min, or serum albumin = lower limit of normal institutional range (LLN).
- •10.The patient’s relevant toxicities/effects of prior therapy (surgery, radiotherapy) must have recovered to a stable or chronic (grade 1) level.
- •11.The patient agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Patients must notify the principal investigator if they themselves or their partner becomes pregnant.
- •12.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
排除标准
- •1.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 (including serum tumor markers, if available) >6 months after the end of the last cycle of adjuvant chemotherapy or =12 months for oxaliplatin-containing regimens.)
- •2.The patient has received prior radiotherapy to >25% of bone marrow. (Radiation therapy as a part of standard adjuvant chemoradiotherapy for rectal cancer >6 months prior to study entry is allowed.)
- •3.The patient has documented and/or symptomatic brain metastases.
- •4.The patient has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry.
- •5.The patient has received previous therapy with monoclonal antibodies.
- •6.The patient has received previous therapy with any agent that targets the epidermal growth factor receptor.
- •7.The patient has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the patient or the study.
- •8.The patient is on chronic non-topical 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.
- •9.The patient has a known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •10.The patient has a known allergy to any of the treatment components.
- •11.The patient has an acute or subacute intestinal occlusion.
- •12.The patient has peripheral neuropathy = grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 3.0).
- •13.The patient has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- •14.The patient, if female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin [ßHCG] test) or breast-feeding.
- •15.The patient has received a prior autologous or allogeneic organ or tissue transplantation.
- •16.The patient has interstitial pneumonia or interstitial fibrosis of the lung.
- •17.The patient has pleural effusion or ascites that causes = grade 2 dyspnea.
- •18.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.
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