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Colorectal CancerPhase 3NCT00062426

Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer

A Phase 3 study testing bevacizumab, capecitabine and fluorouracil in people with Colorectal Cancer, run by Prologue Research International at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
bevacizumab, capecitabine and fluorouracil
How many people
Not given
Where
52 sitesUnited States
Study dates
May 2003to Feb 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • Advanced Oncology Associates

    Armonk, New York, 10504

  • Peachtree Hematology and Oncology Consultants, P.C.

    Atlanta, Georgia, 30309

  • Lone Star Oncology

    Austin, Texas, 78759

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Lynn Regional Cancer Center West

    Boca Raton, Florida, 33428

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403-1206

  • Charleston Hematology-Oncology, P.A.

    Charleston, South Carolina, 29403

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Hematology Oncology Consultants Inc

    Columbus, Ohio, 43235

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Rocky Mountain Cancer Centers - Midtown

    Denver, Colorado, 80218

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • North Shore Hematology/Oncology Associates, P.C.

    East Setauket, New York, 11733

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Arena Oncology Associates

    Great Neck, New York, 11021

  • California Cancer Care, Inc.

    Greenbrae, California, 94904-2007

  • Physicians East - Quadrangle

    Greenville, North Carolina, 27834

  • Jackson Oncology Associates, PLLC

    Jackson, Mississippi, 39202

  • Florida Oncology Associates

    Jacksonville, Florida, 32207

  • McCleod Cancer and Blood Center

    Johnson City, Tennessee, 37604

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • Valley Tumor Medical Group

    Lancaster, California, 93534

  • Memphis Cancer Center

    Memphis, Tennessee, 38119

  • West Clinic

    Memphis, Tennessee, 38120

  • Medical Consultants

    Milwaukee, Wisconsin, 53215-3690

  • Sarah Cannon Cancer Center at Centennial Medical Center

    Nashville, Tennessee, 37203

  • St. Vincents Comprehensive Cancer Center

    New York, New York, 10011

  • New York University Medical Center

    New York, New York, 10016

  • Hematology and Oncology Consultants, P.A.

    Orlando, Florida, 32804

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1270

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Hematology Oncology Associates of theTreasure Coast - Port St. Lucie

    Port Saint Lucie, Florida, 34952

  • Raleigh Hematology/Oncology Associates, P.A. - Wake Practice

    Raleigh, North Carolina, 27609-7300

  • Cancer and Blood Institute of the Desert

    Rancho Mirage, California, 92270

  • West Suburban Center for Cancer Care

    River Forest, Illinois, 60305

  • Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Hematology/Oncology of Salem

    Salem, Oregon, 97301

  • South Texas Oncology and Hematology

    San Antonio, Texas, 78207

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Center for Cancer Prevention and Care at Scott and White Clinic

    Temple, Texas, 76508

  • Northwestern Connecticut Oncology-Hematology Associates

    Torrington, Connecticut, 06790

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

  • New York Medical College

    Valhalla, New York, 10595

  • Cooper Cancer Institute at Cooper University Hospital

    Voorhees Township, New Jersey, 08043

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

Other trials in United States

About this study

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)

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.

Read the detailed description

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.

Keywords
adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2003 (estimated)
  2. Study startMay 2003
  3. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00062426
Sponsor's protocol ID
CDR0000304771
Other IDs
PROLOGUE-SANOFI-ARD5099, SANOFI-ARD5099
Status last verified
Apr 2004
First submitted
5 Jun 2003
Last updated
6 Nov 2013
Results posted
No

Publications

  • Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.

    PubMed 21245868

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab, capecitabine and fluorouracil in people with Colorectal Cancer, run by Prologue Research International at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00062426, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

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