A Study of Ramucirumab or Icrucumab in Colorectal Cancer

NCT ID: NCT01111604

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-12-31

Brief 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.

Detailed 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.

Conditions

Colon Cancer; Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mFOLFOX-6

mFOLFOX-6

Group Type: ACTIVE_COMPARATOR

mFOLFOX-6

Intervention Type: DRUG

Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Ramucirumab

mFOLFOX-6 + Ramucirumab

Group Type: EXPERIMENTAL

Ramucirumab

Intervention Type: BIOLOGICAL

8 mg/kg IV Q2W

mFOLFOX-6

Intervention Type: DRUG

Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Icrucumab

mFOLFOX-6 + Icrucumab

Group Type: EXPERIMENTAL

Icrucumab

Intervention Type: BIOLOGICAL

15 mg/kg IV Q2W

mFOLFOX-6

Intervention Type: DRUG

Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

Interventions

Ramucirumab

8 mg/kg IV Q2W

Intervention Type: BIOLOGICAL

Icrucumab

15 mg/kg IV Q2W

Intervention Type: BIOLOGICAL

mFOLFOX-6

Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

Intervention Type: DRUG

Other Intervention Names

IMC-1121B; LY3009806; IMC-18F1; LY3012212

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Cincinnati, Ohio, United States

ImClone Investigational Site

Columbia, South Carolina, United States

ImClone Investigational Site

Nashville, Tennessee, United States

ImClone Investigational Site

Calgary, Alberta, Canada

ImClone Investigational Site

Edmonton, Alberta, Canada

ImClone Investigational Site

Kelowna, British Columbia, Canada

ImClone Investigational Site

Surrey, British Columbia, Canada

ImClone Investigational Site

Vancouver, British Columbia, Canada

ImClone Investigational Site

Halifax, Nova Scotia, Canada

ImClone Investigational Site

Hamilton, Ontario, Canada

ImClone Investigational Site

London, Ontario, Canada

ImClone Investigational Site

Mississauga, Ontario, Canada

ImClone Investigational Site

Oshawa, Ontario, Canada

ImClone Investigational Site

Ottawa, Ontario, Canada

ImClone Investigational Site

Toronto, Ontario, Canada

ImClone Investigational Site

Windsor, Ontario, Canada

ImClone Investigational Site

Montreal, Quebec, Canada

Countries

United States; Canada

References

Moore M, Gill S, Asmis T, Berry S, Burkes R, Zbuk K, Alcindor T, Jeyakumar A, Chan T, Rao S, Spratlin J, Tang PA, Rothenstein J, Chan E, Bendell J, Kudrik F, Kauh J, Tang S, Gao L, Kambhampati SR, Nasroulah F, Yang L, Ramdas N, Binder P, Strevel E. Randomized phase II study of modified FOLFOX-6 in combination with ramucirumab or icrucumab as second-line therapy in patients with metastatic colorectal cancer after disease progression on first-line irinotecan-based therapy. Ann Oncol. 2016 Dec;27(12):2216-2224. doi: 10.1093/annonc/mdw412. Epub 2016 Oct 11.

Reference Type: DERIVED

PMID: 27733377 (View on PubMed)

Other Identifiers

CP20-0801

Identifier Type: OTHER

Identifier Source: secondary_id

I4Y-IE-JCDB

Identifier Type: OTHER

Identifier Source: secondary_id

13942

Identifier Type: -

Identifier Source: org_study_id