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Brief Title: Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
Official Title: Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen
Study ID: NCT00291785
Brief Summary: CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Policlinico Universitario "A.Gemelli", Rome, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Name: Barone C., M.D.
Affiliation: Policlinico Universitario "A.Gemelli"
Role: PRINCIPAL_INVESTIGATOR