An Open Label, Prospective, Non-comparative Single Arm Study to Evaluate Efficacy And Safety Of Oxaliplatin as an Adjuvant to Chemotherapy in Metastatic Colon Cancer. - NI

Cipla Ltd0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Willing to provide written informed consent and comply with study procedures.
•2.Male or Female Subjects with greater than or equal to 18 yrs and less than or equal to 70 yrs.
•3.Subjects with histologically or cytologically proven metastatic colon cancer with atleast one measurable lesion.
•4.Performance Status ECOG of 0-2.
•5.Platelet count greater than or equal to 100,000/cu mm.
•6.Adequate renal function (Creatinine less than 1.5 mg/dL).
•7.Adequate liver function (Bilirubin less than 2.0 mg/dL, Transaminase levels less than 2.5 times the upper normal limit).
•8.Life expectancy of atleast 12 months as per the investigators discretion.

•1.Subjects who have received chemotherapy for metastatic colon cancer within a period of 12 months prior to screening.
•2.Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks prior to randomization.
•3.Pregnant or lactating women or women of child bearing potential not using a contraceptive method.
•4.A serious uncontrolled medical disorder that, in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
•5.Known metastases in the central nervous system and grade three sensory neuropathy as per NCI CTC grading for neuropathy.
•6.Subjects with interstitial lung disease or pulmonary fibrosis.
•7.Evidence of any other serious illness or medical conditions.
•8.Subjects with known allergy to Oxaliplatin or other platinum compounds

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