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

Primary Purpose

Colorectal Cancer (CRC)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Irinotecan
5-Fluorouracil (bolus)
5-Fluorouracil (infusional)
Leucovorin calcium
CT-322
Bevacizumab
Bevacizumab Placebo (saline solution)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer (CRC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Acrc/Arizona Clinical Research Center, Inc.
  • Compassionate Cancer Care Medical Group Inc
  • Compassionate Cancer Care Medical Group, Inc
  • Sharp Memorial Hospital
  • Florida Cancer Specialists
  • Midwest Center For Hematology/Oncology
  • Cancer Center Of Kansas
  • Gurtler, Jayne
  • Guthrie Clinic, Ltd
  • Pharma Resource
  • Sarah Cannon Research Institute
  • University Of Texas M.D. Anderson Cancer Center
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322

Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)

Outcomes

Primary Outcome Measures

Progression free survival based on tumor assessments (CT/MRI)

Secondary Outcome Measures

Overall survival (OS), defined as the time the subject is randomized until death, in each arm
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
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

Full Information

First Posted
February 23, 2009
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00851045
Brief Title
Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer (CRC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar
Intervention Description
Solution, IV, 180 mg/m2, Q14 days, Until PD
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil (bolus)
Intervention Description
Solution, IV, 400 mg/m2, Q14 days, Until PD
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil (infusional)
Intervention Description
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Intervention Type
Drug
Intervention Name(s)
Leucovorin calcium
Intervention Description
Solution, IV, 400 mg/m2, Q14 days, Until PD
Intervention Type
Drug
Intervention Name(s)
CT-322
Other Intervention Name(s)
BMS-844203
Intervention Description
Solution, IV, 2 mg/kg, Q7 days, Until PD
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Solutions, IV, 5 mg/kg, Q14 days, Until PD
Intervention Type
Drug
Intervention Name(s)
Bevacizumab Placebo (saline solution)
Other Intervention Name(s)
Saline Solution
Intervention Description
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Overall survival (OS), defined as the time the subject is randomized until death, in each arm
Time Frame
every 12 weeks
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Acrc/Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Compassionate Cancer Care Medical Group Inc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Compassionate Cancer Care Medical Group, Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Midwest Center For Hematology/Oncology
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States
Facility Name
Cancer Center Of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Gurtler, Jayne
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Guthrie Clinic, Ltd
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Pharma Resource
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University Of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution
City
Bahia Blanca
State/Province
Buenos Aires
ZIP/Postal Code
8000
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution
City
Terni
ZIP/Postal Code
05100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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