RANDOMIZED PHASE II STUDY OF URACIL / FTORAFUR ORAL (UFT) PLUS LEUCOVORINE 5-FLUOROURACIL PARENTERAL AND LEUCOVARIN IN PATIENTS WITH METASTASIC COLORECTAL CANCER

BRISTOL MYERS SQUIBB PERÚ S.A.,0 个研究点目标入组 0 人开始时间: 1998年11月13日最近更新: 2023年9月4日

适应症

试验速览

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•Patients with histologically confirmed metastatic colorectal adenocarcinoma.
•Men or women whose physiological age is 18 years and 75 years old.
•Patients who have received adjuvant colorectal treatment at least 6 months before enrolling in the study.
•Adjuvant therapy at least 6 months before enrolling in the study. Adjuvant therapy may have been given before and / or after surgery. This includes any modality.
•Potentially fertile women may receive treatment, but 72 hours before the start of the study, the results of the pregnancy test performed on serum or urine should have been evaluated.
•Performance status score according to the ECOG scale must be 0 - 2.
•Patients´ disease must be measurable two-dimensionally, or it must be an evaluable disease, located outside the fields that have been previously irradiated.
•The functioning of the bone marrow should be adequate: absolute granulocyte count, neutrophils of segmented nuclei and neutrophils with nuclei in bands greater than or equal to 2000 / mm3, platelet count greater than or equal to 100000 / mm3
•Total bilirubin less than or equal to 1.5 times the upper limit of the normal institutional.
•Creatinine less than or equal to 1.5 times the upper limit of the normal institutional.
•Informed Consent of the patient must be obtained in accordance with the oaths of the local Ethics Committee.
•Patients must be available for follow-up.

•Participants who have undergone any type of previous treatment for metastatic disease, with the exception of radiotherapy applied to locally treat the symptomatic disease.
•Patients who have had a serious, uncontrolled concurrent medical disorder.
•Patients with a previous neoplasm, except skin cancer of the epithelial cells or localized cervical cancer, appropriately treated. Patients with distant histories of other tumors already cured may enter after discussing it with the sponsor and once their approval has been obtained.
•Pregnant or breastfeeding patients, or potentially fertile women who are not applying an adequate method for birth control.

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