A Study of Ramucirumab or Icrucumab in Colorectal Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Colon Cancer; Rectal Cancer

Treatments: Drug: mFOLFOX-6; Biological: Icrucumab; Biological: Ramucirumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01111604

CP20-0801 (Other Identifier)

I4Y-IE-JCDB (Other Identifier)

13942

Details and patient eligibility

About

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.

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.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 3 patient groups

mFOLFOX-6

Active Comparator group

Description:

mFOLFOX-6

Treatment:

Drug: mFOLFOX-6

mFOLFOX-6 + Ramucirumab

Experimental group

Description:

mFOLFOX-6 + Ramucirumab

Treatment:

Biological: Ramucirumab

Drug: mFOLFOX-6

mFOLFOX-6 + Icrucumab

Experimental group

Description:

mFOLFOX-6 + Icrucumab

Treatment:

Biological: Icrucumab

Drug: mFOLFOX-6