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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00851045
First received: February 23, 2009
Last updated: January 13, 2012
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Colorectal Cancer (CRC)
 Drug: Irinotecan
Drug: 5-Fluorouracil (bolus)
Drug: 5-Fluorouracil (infusional)
Drug: Leucovorin calcium
Drug: CT-322
Drug: Bevacizumab
Drug: Bevacizumab Placebo (saline solution)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS), defined as the time the subject is randomized until death, in each arm [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
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 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: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851045

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00851045     History of Changes
Other Study ID Numbers: CA196-004, EUDRACT # 2008-006561-89
Study First Received: February 23, 2009
Last Updated: January 13, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Istituto Superiore de Sanita (ISS)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Irinotecan
Bevacizumab
Leucovorin
 Levoleucovorin
Angiogenesis Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013