Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

September 23, 2015 updated by: Bristol-Myers Squibb

A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina, 8000
        • Local Institution
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Local Institution
  • Italy
      • Terni, Italy, 05100
        • Local Institution
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Acrc/Arizona Clinical Research Center, Inc.
    • California
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care Medical Group Inc
      • Riverside, California, United States, 92501
        • Compassionate Cancer Care Medical Group, Inc
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists
    • Illinois
      • Joliet, Illinois, United States, 60432
        • Midwest Center for Hematology/Oncology
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Gurtler, Jayne
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic, Ltd
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Pharma Resource
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ECOG Performance Status (PS) ≤1
  • Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
  • Measurable disease by RECIST guidelines
  • Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
  • Available paraffin embedded tumor tissue
  • Willing to give a whole blood sample for the study of proteins and genetic polymorphisms

Exclusion Criteria:

  • Less than 28 days elapsed since major surgery at time of randomization
  • Known CNS metastases
  • Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
  • Uncontrolled hypertension
  • Clinically significant cardiovascular disease
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
  • Known HIV Positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Drug: Irinotecan
Solution, IV, 180 mg/m2, Q14 days, Until PD
Other Names:
  • Camptosar
Drug: 5-Fluorouracil (bolus)
Solution, IV, 400 mg/m2, Q14 days, Until PD
Drug: 5-Fluorouracil (infusional)
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Drug: Leucovorin calcium
Solution, IV, 400 mg/m2, Q14 days, Until PD
Drug: CT-322
Solution, IV, 2 mg/kg, Q7 days, Until PD
Other Names:
  • BMS-844203
ACTIVE_COMPARATOR: Arm 2
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Drug: Irinotecan
Solution, IV, 180 mg/m2, Q14 days, Until PD
Other Names:
  • Camptosar
Drug: 5-Fluorouracil (bolus)
Solution, IV, 400 mg/m2, Q14 days, Until PD
Drug: 5-Fluorouracil (infusional)
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Drug: Leucovorin calcium
Solution, IV, 400 mg/m2, Q14 days, Until PD
Drug: Bevacizumab
Solutions, IV, 5 mg/kg, Q14 days, Until PD
Other Names:
  • Avastin
Drug: Bevacizumab Placebo (saline solution)
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
Other Names:
  • Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival based on tumor assessments (CT/MRI)
Time Frame: Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent
Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS), defined as the time the subject is randomized until death, in each arm
Time Frame: every 12 weeks
every 12 weeks
Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator
Time Frame: every 6 weeks
every 6 weeks
Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (ESTIMATE)

February 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA196-004
  • EUDRACT # 2008-006561-89

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Cancer (CRC)

Clinical Trials on Irinotecan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe