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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851045
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE February 23, 2009
First Posted Date  ICMJE February 25, 2009
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE October 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00851045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2010)
  • Overall survival (OS), defined as the time the subject is randomized until death, in each arm [ Time Frame: 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
  • Overall survival (OS) in each arm [ Time Frame: every 12 weeks ]
  • Objective tumor response rate (ORR) in each arm [ Time Frame: every 6 weeks ]
  • Duration of response in each of the two treatment arms [ Time Frame: every 6 weeks ]
  • Time to response in each of the two treatment arms [ Time Frame: Every 6 weeks ]
  • Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm [ Time Frame: weekly ]
  • Pharmacokinetics of CT-322, irinotecan , 5-FU and leucovorin when administered in combination [ Time Frame: Multiple timepoints ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer (CRC)
Intervention  ICMJE
  • Drug: Irinotecan
    Solution, IV, 180 mg/m2, Q14 days, Until PD
    Other Name: 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 Name: BMS-844203
  • Drug: Bevacizumab
    Solutions, IV, 5 mg/kg, Q14 days, Until PD
    Other Name: Avastin
  • Drug: Bevacizumab Placebo (saline solution)
    Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
    Other Name: Saline Solution
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
    Interventions:
    • Drug: Irinotecan
    • Drug: 5-Fluorouracil (bolus)
    • Drug: 5-Fluorouracil (infusional)
    • Drug: Leucovorin calcium
    • Drug: CT-322
  • Active Comparator: Arm 2
    Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
    Interventions:
    • Drug: Irinotecan
    • Drug: 5-Fluorouracil (bolus)
    • Drug: 5-Fluorouracil (infusional)
    • Drug: Leucovorin calcium
    • Drug: Bevacizumab
    • Drug: Bevacizumab Placebo (saline solution)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2012)
17
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2009)
116
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Italy,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00851045
Other Study ID Numbers  ICMJE CA196-004
EUDRACT # 2008-006561-89
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP