PER-015-10已完成未知
PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF FOLFOX + CT-011 VERSUS FOLFOX ALONE ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH COLORECTAL ADENOCARCINOMA PREVIOUSLY UNTREATED FOR METASTATIC DISEASE
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 90（—）
入选标准
- •The patient´s age is 18 years or older, of both sexes.
- •Adenocarcinoma of the colon or rectum confined by histological or cytological study.
- •Patients with metastatic disease who are eligible for first-line chemotherapy of FOLFOX. An adjuvant or neoadjuvant is allowed to be administered at least 12 months before metastatic disease.
- •Measurable disease defined by the identification of at least 1 measurable CT lesion according to RECIST criteria. MRI with contrast can be used in situations where CT results are inconsistent with respect to the extent of liver disease. A PET should not be used to assess measurability or response.
- •ECOG functional status <1
- •Serum albumin greater than 3.5
- •At least 4 weeks before major surgery or radiation therapy.
- •Life expectancy> 3 months
- •Hematology; RAN> 1.5X10 ^ / 1, platelets> 100x10 ^ 9/1.
- •Adequate renal function creatinine <1.5 x the upper limit of normal (LSN) or calculated creatinine clearance of> 50cc / min.
- •Adequate liver functions: bilirubin less than 1.5 mg / dl; (except in patients with Gilbert´s syndrome, who must have a total bilirubin lower than 3.0 mg / dl). AST or ALT <3 x LSN, or <5 x ULN, if liver metastases are known.
- •Normal cardiac function: There is no active coronary artery disease; there is no Class II, ITI or IV disease of the New York Heart Association; There is no arrhythmia that requires treatment.
- •Women of childbearing age whose pregnancy tests (urine or blood) show negative results and who commit to using effective contraceptive methods. Reliable contraceptives should be used from the test test and should be continued throughout the study and for at least four months since the last treatment with CT-011. A woman of childbearing age is defined as one who is biologically capable of becoming pregnant.
- •Men participating in this study should agree to use a form of reliable barrier contraceptives for the duration of the study and for 4 months since the last treatment with CT-011.
- •Informed consent signed and dated in writing must be obtained to participate in this clinical trial before any study procedure.
排除标准
- •Patients who received adjuvant or neoadjuvant therapy for a non-metastatic disease given in the last 12 months.
- •Patients who have received oxaliplatin in a period of 12 months before the diagnosis of metastatic disease.
- •Patients in simultaneous treatment against cancer other than those allowed in the study.
- •Patients treated with concurrent steroids, other than those authorized for routine antiemetics, or inhaling steroids.
- •Presence of clinically apparent or suspicious brain metastases.
- •Patients who have had myocardial infarction, congestive heart failure or significant arrhythmia in the last 6 months.
- •Serious active infection at the time of the previous review of the study. Conditions requiring antibiotics must be completely resolved and the patient must be without antibiotics before starting the treatment protocol.
- •Active autoimmune disorders / conditions or a history of having them, including ulcerative colitis or active diverticulitis. Chronic diabetes mellitus, vitiligo or stable hypothyroidism will not be considered exclusion criteria.
- •Women who are pregnant or breastfeeding.
- •Concurrent active malignancy.
- •Ascites, pleural effusion, or osteoblastic bone metastases as the only site of the disease.
- •Other previous malignant neoplasms, except for non-melanoma cured skin cancer or cervical carcinoma in situ treated curatively or malignant neoplasms properly treated without evidence of activity for more than 5 years.
- •Patients with a condition that can interfere with the subjects´ ability to understand the study requirements.
- •Patients with a history of life-threatening allergic reactions to food or medication.
- •Patients with symptomatic peripheral neuropathy> Grade 1.
- •Known HIV positive, hepatitis B surface antigen or hepatitis C antibody.
研究者
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