Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
NCT ID: NCT00066846
Last Updated: 2013-06-20
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
INTERVENTIONAL
2003-08-31
2007-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
NCT00062426
Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
NCT00449163
A Study to Evaluate Avastin in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
NCT00109226
Study of Bevacizumab, Erlotinib, FOLFOX for Patients With Untreated Metastatic Colorectal Cancer
NCT00116506
Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.
NCT00337389
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the response rate of patients treated with bevacizumab, fluorouracil, and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy.
* Determine the time to progression and overall survival of patients treated with this regimen.
* Determine the safety of administering "bolus" and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment regimens.
* Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks) and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1, 8, 15, 22, 29, and 36.
* Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29, 30, 43, and 44.
For both regimens, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for tumor response and survival.
PROJECTED ACCRUAL: Various NCI-designated Clinical Cancer Centers and other medical institutions across the United States will participate in this study. A total of 35-125 patients will be accrued for this study within 3 months.
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.
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bevacizumab
fluorouracil
leucovorin calcium
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 colorectal adenocarcinoma
* Stage IV (metastatic) disease
* Not curable by surgery or radiotherapy
* Must have received prior standard chemotherapy regimens, including oxaliplatin and irinotecan, and meet both of the following criteria:
* Disease progression during or after irinotecan-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant irinotecan-based therapy
* Disease progression during or after oxaliplatin-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant oxaliplatin-based therapy
* No brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL (transfusion allowed)
* No evidence of bleeding diathesis or coagulopathy
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* AST less than 5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 5 times ULN
* PT and INR no greater than 1.5 times ULN
* PTT no greater than ULN
Renal
* Creatinine no greater than 1.5 times ULN
* Proteinuria less than grade 1 OR
* Proteinuria less than 500 mg/24 hours
Cardiovascular
* No prior stroke
* No uncontrolled high blood pressure
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart disease
* No thromboembolism within the past 6 months
Other
* Chemonaive
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation
* No significant traumatic injury within the past 6 weeks
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents
* No active infection
* No psychiatric illness or social situation that would preclude study compliance
* No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture
* No CNS disease, including either of the following:
* Primary brain tumor
* Seizures not controlled with standard medical therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 8 weeks since prior monoclonal antibody therapy
* No prior bevacizumab
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)
Surgery
* More than 6 weeks since prior major surgical procedure or open biopsy
* More than 7 days since prior fine needle aspiration or core biopsy
* No concurrent surgery
Other
* Recovered from prior therapy
* At least 3 weeks since prior cytotoxic agents
* No concurrent therapeutic anticoagulation
* Prophylactic anticoagulation of venous access devices allowed provided PT/INR or PTT criteria are met
* No concurrent chronic aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational or commercial agents for the malignancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Helen X. Chen, MD
Role: PRINCIPAL_INVESTIGATOR
NCI - Investigational Drug Branch
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Providence Alaska Medical Center
Anchorage, Alaska, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Cancer Care of Maine
Bangor, Maine, United States
Saint Joseph Mercy Health System
Ann Arbor, Michigan, United States
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, United States
Ireland Cancer Center
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Sioux Valley Clinics - Oncology
Sioux Falls, South Dakota, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Massey Cancer Center
Richmond, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chen HX, Mooney M, Boron M, Vena D, Mosby K, Grochow L, Jaffe C, Rubinstein L, Zwiebel J, Kaplan RS. Phase II multicenter trial of bevacizumab plus fluorouracil and leucovorin in patients with advanced refractory colorectal cancer: an NCI Treatment Referral Center Trial TRC-0301. J Clin Oncol. 2006 Jul 20;24(21):3354-60. doi: 10.1200/JCO.2005.05.1573.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTEP-TRC-0301
Identifier Type: -
Identifier Source: secondary_id
CDR0000320506
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.