Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00062426 |
Recruitment Status
:
Completed
First Posted
: June 6, 2003
Last Update Posted
: November 6, 2013
|
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RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different combinations may kill more tumor cells. Monoclonal antibodies, such as bevacizumab (Avastin™), can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known which regimen works better in treating advanced colorectal cancer.
PURPOSE: This randomized phase III trial is to see if oxaliplatin and bevacizumab work better when combined with either fluorouracil and leucovorin or capecitabine in treating patients who have metastatic or recurrent colorectal cancer.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Biological: bevacizumab Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin | Phase 3 |
OBJECTIVES:
- Compare the incidence of grade 3 and 4 toxic effects occurring within the first 12 weeks of treatment with 2 different schedules of oxaliplatin, bevacizumab (Avastin™), leucovorin calcium, and fluorouracil or with oxaliplatin, Avastin™, and capecitabine in patients with advanced colorectal cancer.
- Compare the overall response rate, progression-free survival, and time to treatment failure in patients treated with these regimens.
- Compare the composite toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive bevacizumab (Avastin™) IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil (5-FU) IV over 46 hours beginning on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 10 minutes and 5-FU IV over 3 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 3 months for at least 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 375 patients (125 per treatment arm) will be accrued for this study.
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Prospective Study Comparing Three Regimens Of Eloxatin ™ Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer (Tree Study) |
Study Start Date : | May 2003 |
Actual Study Completion Date : | February 2011 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic or recurrent disease not amenable to potentially curative treatment
-
At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Histological or cytological confirmation is required for a solitary target lesion
- No CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGPT and SGOT no greater than 3 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 30 mL/min
Cardiovascular
- No myocardial infarction within the past 6 months
- No clinical evidence of congestive heart failure
- No unstable coronary artery disease
Pulmonary
- No interstitial pneumonia
- No extensive symptomatic fibrosis of the lungs
Gastrointestinal
- Able to tolerate oral medication
- No lack of physical integrity of the upper gastrointestinal tract
- No malabsorption syndrome
- No swallowing difficulties
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- No other concurrent serious illness
- No uncontrolled infection
- No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix or any other cancer for which the patient has been off all therapy and in remission for at least 5 years
- No peripheral neuropathy
- No hypersensitivity to any of the study drugs or their ingredients
- No known dihydropyrimidine dehydrogenase deficiency
- No other medical or psychiatric disorder that would preclude giving informed consent or complying with study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic hematopoietic growth factor therapy
- No prior bevacizumab (Avastin™)
Chemotherapy
- At least 6 months since prior adjuvant fluorouracil, leucovorin calcium, and irinotecan
- No prior oxaliplatin
- No prior chemotherapy for metastatic or recurrent disease
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No concurrent radiotherapy unless for the control of bone pain
Surgery
- Recovered from prior surgery
- No prior organ allografts
Other
- More than 4 weeks since prior investigational drugs
- No concurrent iced mouth rinses for the prevention of stomatitis
- No concurrent cold cap alopecia prevention
- No concurrent pyridoxine
- No concurrent sorivudine or chemically-related analogues (e.g., brivudine)
- No concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, or warfarin

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 ClinicalTrials.gov identifier (NCT number): NCT00062426

United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3300 | |
United States, Arizona | |
Arizona Clinical Research Center | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
California Cancer Care, Inc. | |
Greenbrae, California, United States, 94904-2007 | |
Valley Tumor Medical Group | |
Lancaster, California, United States, 93534 | |
Cancer and Blood Institute of the Desert | |
Rancho Mirage, California, United States, 92270 | |
United States, Colorado | |
Rocky Mountain Cancer Centers - Midtown | |
Denver, Colorado, United States, 80218 | |
United States, Connecticut | |
Northwestern Connecticut Oncology-Hematology Associates | |
Torrington, Connecticut, United States, 06790 | |
United States, District of Columbia | |
Lombardi Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Lynn Regional Cancer Center West | |
Boca Raton, Florida, United States, 33428 | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
Florida Oncology Associates | |
Jacksonville, Florida, United States, 32207 | |
Hematology and Oncology Consultants, P.A. | |
Orlando, Florida, United States, 32804 | |
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie | |
Port St. Lucie, Florida, United States, 34952 | |
Palm Beach Cancer Institute | |
West Palm Beach, Florida, United States, 33401 | |
United States, Georgia | |
Peachtree Hematology and Oncology Consultants, P.C. | |
Atlanta, Georgia, United States, 30309 | |
United States, Idaho | |
North Idaho Cancer Center | |
Coeur d'Alene, Idaho, United States, 83814 | |
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611 | |
Lutheran General Cancer Care Center | |
Park Ridge, Illinois, United States, 60068-1270 | |
West Suburban Center for Cancer Care | |
River Forest, Illinois, United States, 60305 | |
Saint Anthony Medical Center | |
Rockford, Illinois, United States, 61108 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
United States, Iowa | |
Cedar Rapids Oncology Associates | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
United States, Kansas | |
CCOP - Wichita | |
Wichita, Kansas, United States, 67214-3882 | |
United States, Maryland | |
Greater Baltimore Medical Center and Cancer Center | |
Baltimore, Maryland, United States, 21204 | |
United States, Mississippi | |
Jackson Oncology Associates, PLLC | |
Jackson, Mississippi, United States, 39202 | |
United States, Missouri | |
Veterans Affairs Medical Center - Kansas City | |
Kansas City, Missouri, United States, 64128 | |
United States, Montana | |
Deaconess Billings Clinic Cancer Center | |
Billings, Montana, United States, 59107-5100 | |
United States, New Jersey | |
Cooper Cancer Institute at Cooper University Hospital | |
Voorhees, New Jersey, United States, 08043 | |
United States, New York | |
Advanced Oncology Associates | |
Armonk, New York, United States, 10504 | |
North Shore Hematology/Oncology Associates, P.C. | |
East Setauket, New York, United States, 11733 | |
Arena Oncology Associates | |
Great Neck, New York, United States, 11021 | |
St. Vincents Comprehensive Cancer Center | |
New York, New York, United States, 10011 | |
New York University Medical Center | |
New York, New York, United States, 10016 | |
New York Medical College | |
Valhalla, New York, United States, 10595 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
Southeastern Medical Oncology Center | |
Goldsboro, North Carolina, United States, 27534 | |
Physicians East - Quadrangle | |
Greenville, North Carolina, United States, 27834 | |
Raleigh Hematology/Oncology Associates, P.A. - Wake Practice | |
Raleigh, North Carolina, United States, 27609-7300 | |
United States, Ohio | |
Hematology Oncology Consultants Inc | |
Columbus, Ohio, United States, 43235 | |
United States, Oregon | |
Hematology/Oncology of Salem | |
Salem, Oregon, United States, 97301 | |
United States, Pennsylvania | |
Pennsylvania Oncology Hematology Associates | |
Philadelphia, Pennsylvania, United States, 19106 | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, South Carolina | |
Charleston Hematology-Oncology, P.A. | |
Charleston, South Carolina, United States, 29403 | |
United States, Tennessee | |
McCleod Cancer and Blood Center | |
Johnson City, Tennessee, United States, 37604 | |
Memphis Cancer Center | |
Memphis, Tennessee, United States, 38119 | |
West Clinic | |
Memphis, Tennessee, United States, 38120 | |
Sarah Cannon Cancer Center at Centennial Medical Center | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Lone Star Oncology | |
Austin, Texas, United States, 78759 | |
Medical City Dallas Hospital | |
Dallas, Texas, United States, 75230 | |
South Texas Oncology and Hematology | |
San Antonio, Texas, United States, 78207 | |
Center for Cancer Prevention and Care at Scott and White Clinic | |
Temple, Texas, United States, 76508 | |
United States, Wisconsin | |
Medical Consultants | |
Milwaukee, Wisconsin, United States, 53215-3690 |
Study Chair: | Richard A. Gams, MD | Prologue Research International | |
OverallOfficial: | Lauri Welles, MD | Sanofi-Synthelabo |
Publications:
ClinicalTrials.gov Identifier: | NCT00062426 History of Changes |
Other Study ID Numbers: |
CDR0000304771 PROLOGUE-SANOFI-ARD5099 SANOFI-ARD5099 |
First Posted: | June 6, 2003 Key Record Dates |
Last Update Posted: | November 6, 2013 |
Last Verified: | April 2004 |
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer |
stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
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 Bevacizumab Oxaliplatin Capecitabine Fluorouracil |
Levoleucovorin Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Antidotes Protective Agents |