Colon Cancer Clinical Trial

A Study of Ramucirumab or Icrucumab in Colorectal Cancer

Summary

The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

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Full Description

The purpose of this study is to evaluate the progression-free survival (PFS) in participants 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 participant care.

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Eligibility Criteria

Inclusion Criteria:

Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab)
Age ≥ 18 years
Life expectancy of ≥ 6 months
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 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 Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered > 12 months prior to randomization)
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 participant 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 participant 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

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

158

Study ID:

NCT01111604

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

158

Study ID:

NCT01111604

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

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