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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. Identifier: NCT00851045
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Irinotecan

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 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

Primary Outcome Measures :
  1. 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 Measures :
  1. Overall survival (OS), defined as the time the subject is randomized until death, in each arm [ Time Frame: every 12 weeks ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851045

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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
Local Institution
Bahia Blanca, Buenos Aires, Argentina, 8000
Local Institution
Capital Federal, Buenos Aires, Argentina, 1426
Local Institution
Terni, Italy, 05100
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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Responsible Party: Bristol-Myers Squibb Identifier: NCT00851045    
Other Study ID Numbers: CA196-004
EUDRACT # 2008-006561-89
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmaceutical Solutions
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Calcium-Regulating Hormones and Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents