A Study in Second Line Metastatic Colorectal Cancer

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ramucirumab — BIOLOGICAL
  8 milligrams / kilogram (mg/kg) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
• Placebo — BIOLOGICAL
  Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
• Irinotecan — DRUG
  180 milligrams/square meter (mg/m\^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
• Folinic Acid — DRUG
  400 mg/m\^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
• 5-Fluorouracil — DRUG
  400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

Study Details

The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.

Key Dates

Start date

Dec 2, 2010

Status verified

Sep 2019

Primary completion

Jul 17, 2014

Completion

Jun 20, 2016

Study Design

Enrollment

1,072 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: FOLFIRI + Ramucirumab
• Placebo Comparator: FOLFIRI + Placebo

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Randomization to Date of Death from Any Cause Up to 39.36 Months ]

Locations (92)

Find similar trials in Sedona, AZ

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