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An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With IMC 1121B or IMC 18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Met

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Conditions:		Colon Cancer - Rectal Cancer
Purpose:		The purpose of this study is to determine if patients with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus IMC-1121B, or standard chemotherapy plus IMC-18F1.
Study Summary:		The purpose of this study is to evaluate the progression-free survival (PFS) in patients with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid [FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line therapy. During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of patient care.
Criteria:		Inclusion Criteria: - Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI, FOLFIRI + bevacizumab) - Age ≥ 18 years - Life expectancy of ≥ 6 months - ECOG PS (Eastern Cooperative Oncology Group Performance Status) 0-1 at study entry - Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication - Provided signed informed consent Exclusion Criteria: - Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic CRC - Has documented and/or symptomatic brain or leptomeningeal metastases - Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders - On chronic non-topical corticosteroid treatment. A patient discontinuing such treatment > 3 months prior to randomization is eligible - Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy - Has a concurrent active malignancy. A patient with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years - If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG] test) or lactating - Has received a prior autologous or allogeneic organ or tissue transplantation - Has undergone major surgery within 28 days prior to randomization - Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization - Has an elective or planned major surgery to be performed during the course of the trial - Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization
NCT ID:		NCT01111604
Primary Contact:		Study Director E-mail: ClinicalTrials @ImClone.com ImClone LLC E-Mail: There may be multiple sites in this clinical trial Email: ClinicalTrials@ImClone.com
Backup Contact:		N/A
Location Contact:		Jackson, Tennessee 38301 United States There is no listed contact information for this specific location. Site Status: Not yet recruiting

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