A Study of Ramucirumab or Icrucumab in Colorectal Cancer

Eli Lilly and Company158 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Colon Cancer Rectal Cancer

Interventions

RamucirumabBIOLOGICAL

8 mg/kg IV Q2W

IcrucumabBIOLOGICAL

15 mg/kg IV Q2W

mFOLFOX-6DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

ImClone Investigational Site

Cincinnati, Ohio, United States

ImClone Investigational Site

Columbia, South Carolina, United States

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.

Time frame: Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)

Secondary Outcomes

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes \[target or non-target\] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression.

Time frame: Baseline until Disease Progression (Up to 95 Weeks)

Overall Survival (OS)

Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.

Time frame: Baseline Until Death from Any Cause (Up to 163 Weeks)

Duration of Response (DoR)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.