Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
NCT ID: NCT00851045
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2009-10-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC
NCT03303495
Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab
NCT06540326
Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
NCT00544011
Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
NCT00423696
Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer
NCT02497157
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Irinotecan
Solution, IV, 180 mg/m2, Q14 days, Until PD
5-Fluorouracil (bolus)
Solution, IV, 400 mg/m2, Q14 days, Until PD
5-Fluorouracil (infusional)
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Leucovorin calcium
Solution, IV, 400 mg/m2, Q14 days, Until PD
CT-322
Solution, IV, 2 mg/kg, Q7 days, Until PD
Arm 2
Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
Irinotecan
Solution, IV, 180 mg/m2, Q14 days, Until PD
5-Fluorouracil (bolus)
Solution, IV, 400 mg/m2, Q14 days, Until PD
5-Fluorouracil (infusional)
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Leucovorin calcium
Solution, IV, 400 mg/m2, Q14 days, Until PD
Bevacizumab
Solutions, IV, 5 mg/kg, Q14 days, Until PD
Bevacizumab Placebo (saline solution)
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Irinotecan
Solution, IV, 180 mg/m2, Q14 days, Until PD
5-Fluorouracil (bolus)
Solution, IV, 400 mg/m2, Q14 days, Until PD
5-Fluorouracil (infusional)
Solution, IV, 2400 mg/m2, Q14 days, Until PD
Leucovorin calcium
Solution, IV, 400 mg/m2, Q14 days, Until PD
CT-322
Solution, IV, 2 mg/kg, Q7 days, Until PD
Bevacizumab
Solutions, IV, 5 mg/kg, Q14 days, Until PD
Bevacizumab Placebo (saline solution)
Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, United States
Compassionate Cancer Care Medical Group, Inc
Riverside, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Midwest Center For Hematology/Oncology
Joliet, Illinois, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
Gurtler, Jayne
Metairie, Louisiana, United States
Guthrie Clinic, Ltd
Sayre, Pennsylvania, United States
Pharma Resource
East Providence, Rhode Island, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University Of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Local Institution
Bahía Blanca, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Terni, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUDRACT # 2008-006561-89
Identifier Type: -
Identifier Source: secondary_id
CA196-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.