A Study in Second Line Metastatic Colorectal Cancer

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 10-008048
    • Jacksonville, Florida: 10-008048
    • Rochester, Minnesota: 10-008048
    NCT ID: NCT01183780
    Sponsor Protocol Number: 14T-MC-JVBB

About this study

The purpose of this study is to compare the overall survival with ramucirumab combined with FOLFIRI or a placebo and FOLFIRI in patients who have metastatic colorectal cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

This study is ongoing, but not recruiting participants

Inclusion Criteria:

  • Histologically or cytologically confirmed colorectal cancer, excluding primary tumors of appendiceal origin (participants are eligible to enroll irrespective of KRAS mutation status)
  • Confirmed metastatic colorectal cancer (Stage IV)
  • Received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and
    • Experienced radiographic disease progression during first-line therapy
    • Experienced radiographic disease progression ≤ 6 months after the last dose of first-line therapy
    • Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression ≤ 6 months after the last dose of first-line therapy
    • Must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy
    • Must have received at least 1 cycle of first-line therapy that included bevacizumab, oxaliplatin and a fluoropyrimidine in the same cycle
    • Must not have received more than 2 different fluoropyrimidines as part of a first-line regimen
      • Disease progression is not an acceptable reason for discontinuing 1 fluoropyrimidine and starting a second fluoropyrimidine
  • Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted)
    • For rectal cancer, sequential neoadjuvant and adjuvant therapy will count as a single systemic regimen
    • Rechallenge with oxaliplatin is permitted and will be considered part of the first-line regimen for metastatic disease, both initial oxaliplatin treatment and subsequent rechallenge are considered as 1 regimen
  • Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Adequate hematologic, renal and hepatic function
  • Adequate coagulation function [International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal (ULN)).
    • If on full-dose anticoagulation must be on a stable dose of anticoagulant therapy and if on oral anticoagulation, must have an INR ≤3 and have no clinically significant active bleeding or pathological condition that carries a high risk of bleeding
  • Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers and the tumor tissue sample is available
  • Ability to provide signed informed consent

Exclusion Criteria

  • Receipt of bevacizumab ≤ 28 days prior to randomization
  • Receipt of any investigational therapy for non-oncology clinical indication ≤ 28 days prior to randomization
  • Receipt of any previous systemic therapy, other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic colorectal cancer
  • Known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression (currently or in the past)
  • Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to, myocardial infarction, transient ischemic attack, or cerebrovascular accident, ≤12 months prior to randomization
  • Pregnant (confirmed by serum beta human chorionic gonadotropin (ß HCG) test ≤ 7 days prior to randomization) or lactating
  • History of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
  • Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator
  • Grade 3 or higher bleeding event ≤ 3 months prior to randomization
  • Experience of any of the following during first-line therapy with a bevacizumab-containing regimen
    • An arterial thrombotic/thromboembolic event
    • Grade 4 hypertension
    • Grade 3 proteinuria
    • Grade 3-4 bleeding event
    • Bowel perforation
  • Known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes
    • UGT1A1*6/*6
    • UGT1A1*28/*28
    • UGT1A1*6/*28
  • Known allergy to any of the study treatment components, including any components used in the preparation of ramucirumab, or other contraindication to receive the study treatments
  • Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinical meaningful ascites resulting from cirrhosis
    • Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Axel Grothey, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Axel Grothey, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Axel Grothey, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions