EUCTR2008-004281-71-ES进行中（未招募）1 期
Estudio aleatorizado, multicéntrico, de fase 2 para comparar la eficacia de panitumumab en combinación con FOLFOX6m frente a la eficacia de bevacizumab en combinación con FOLFOX6m en pacientes con cáncer colorrectal metastásico, no resecable, con KRAS no mutado y sin tratamiento previoA Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab inCombination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 280
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
- •4.1.1 Disease related
- •Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic disease
- •At least 1 uni-dimensionally measurable lesion of at least 20mm per modified RECIST guidelines (see Appendix E) using conventional techniques (CT scan or MRI) or spiral CT scan. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation and prior to randomization. All sites of disease must be evaluated ? 28 days prior to randomization
- •Wild-type KRAS tumor status confirmed by central laboratory assessment of paraffin-embedded tumor tissue from the primary tumor or metastasis
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix D)
- •4.1.2 Demographic
- •Man or woman 18 years of age or older at the time the informed consent is obtained
- •4.1.3 Laboratory
- •To be performed ? 7 days prior to randomization, unless otherwise specified:
- •Hematologic function within the following limits:
- •? Absolute neutrophil count (ANC) ? 1.5 x 109/L
- •? Platelet count ? 100 x 109/L (without platelet transfusion ? 14 days prior to
- •randomization)
- •? Hemoglobin (Hgb) ? 9.0 g/dL
- •Renal function within the following limits:
- •? Creatinine clearance (GFR) ? 50 mL/min calculated by the Cockcroft- Gault method as follows:
- •o Male creatinine clearance = (140 ? age in years) x (weight in Kg) / (serum creatinine in mg/dL x 72)
- •o Female creatinine clearance = (140 ? age) x (weight in Kg) x 0.85 / (serum creatinine in mg/dL x 72)
- •? Urinary protein ? 30 mg by urinalysis or ? 1+ by dipstick or urine protein creatinine (UPC) ratio ? 0.5 by urinalysis (unless excretion of < 1000 mg of protein per day as determined by 24-hour urine collection).
- •Note: UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formula:
- •[urine protein]/[urine creatinine] - if both urine protein and creatinine are reported in mg/dL.
- •[(urine protein) x0.088]/[urine creatinine] - if urine creatinine is reported in mmol/L.
- •Hepatic function within the following limits:
- •? Total bilirubin ? 1.5 x ULN
- •? Alkaline phosphatase ? 2.5 x ULN (if liver metastases, ? 5 x ULN)
- •? Aspartate aminotransferase (AST) ? 2.5 x ULN (if liver metastases, ? 5 x ULN)
- •? Alanine aminotransferase (ALT) ? 2.5 x ULN (if liver metastases, ? 5 x ULN)
- •Metabolic function within the following limits:
- •? Magnesium ? lower limit of normal
- •Coagulation function within the following limits:
- •? Partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) ? 1.0 x ULN and international normalized ratio (INR) < 1.5
- •Negative pregnancy test ? 3 days prior to randomization (for woman of childbearing potential only)
- •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
- •4.2.1 Disease Related
- •History of prior or concurrent central nervous system (CNS) metastases
- •History of other malignancy, except:
- •? Malignancy treated with curative intent and with no known active disease present for ? 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician
- •? Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- •? Adequately treated cervical carcinoma in situ without evidence of disease
- •? Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •4.2.2 Cancer Therapy
- •Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-EGFr therapy (eg cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
- •Prior adjuvant chemotherapy (including oxaliplatin therapy) for the treatment of
- •colorectal cancer ? 52 weeks prior to randomization with the following exceptions:
- •? Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization
- •Radiotherapy ? 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities.
- •Unresolved toxicities from prior anti-cancer therapy that, in the opinion of the investigator, excludes subject from participation
- •4.2.3 Other Medications
- •Any anticoagulation therapy within 7 days prior to randomization except the use of low-dose warfarin [< 2 mg daily] or low molecular weight heparin or heparin flushes for prophylaxis against central venous catheter thrombosis which is allowed
- •Chronic daily treatment with aspirin (> 325 mg/day) or non-steroidal anti-inflammatory agents known to inhibit platelet function. Treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is also not allowed
- •Infection requiring a course of systemic anti-infectives that was completed ? 14 days before randomization (exception can be made at the judgment of the investigator for oral treatment of an uncomplicated urinary tract infection [UTI])
- •4.2.4 General
- •Significant cardiovascular risk:
- •? Myocardial infarction, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrhythmias requiring medication or unstable angina ? 24 weeks prior to randomization
- •? Uncontrolled blood pressure defined as > 150 mm Hg systole or > 90 mm Hg diastole. Anti-hypertensive medications are allowed if hypertension is stably controlled at the time of randomization.
- •? Previous history of any CNS cerebrovascular ischemia or hemorrhage
- •? Pulmonary embolism, deep vein thrombosis, or other significant venous event ?8 weeks before randomization
- •Significant bleeding risk:
- •? Major surgical procedure, open biopsy, or significant traumatic injury ? 28 days before randomization or not yet recovered from prior major surgery
- •? Anticipation of need for major elective surgical procedures during the course of the study
- •? Minor surgery ?14 days prior to randomization or not yet recovered from prior minor surgery
- •? Core biopsy or other minor procedure ? 7 days prior to randomization (with the exception of insertion of a vascular access device)
- •? Pre-existing bleeding diathesis and coagulopathy
- •? Serious or non-healing wounds, skin ulcers, or unhealed bone fractures
- •? Gastroduodenal ulcer(s) determined by
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