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AzTrials

Colorectal NeoplasmsPhase 3NCT00056459

Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.

A Phase 3 study testing Vatalanib in people with Colorectal Neoplasms and Colonic Neoplasms, run by Novartis at 223 sites in 19 countries.

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

To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vatalanib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,168 participants
Where
223 sitesin 19 countries
Study dates
Feb 2003to Jan 2007
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

Who may be able to join

  • Patients with metastatic colorectal cancer coming for initial chemotherapy
  • Documented metastatic colorectal cancer
  • WHO Performance Status of 0, 1, or 2
  • Measurable tumors
  • Adequate hematologic status, liver and kidney function
  • Life expectancy greater than 12 weeks
  • Written informed consent obtained

Who cannot join

  • History or presence of central nervous system disease
  • Patients with a history of another primary cancer within 5 years
  • Prior chemotherapy for metastatic colorectal cancer
  • Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks before entry to study
  • Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
  • Investigational drugs within 4 weeks before entry to study
Show all 13Show fewer
  • Prior therapy with anti-VEGF agents
  • Any prior therapy with oxaliplatin or allergy to platinum-containing drugs
  • Peripheral neuropathy with functional impairment
  • Female patients who are pregnant or breast feeding
  • Any severe or uncontrolled medical conditions which could prevent participation in study
  • Patients who are taking Coumadin
  • Other protocol-defined inclusion / exclusion criteria may apply

Trial locations and contacts

223 sites in 19 countries.

223 sites in 19 countries

United States145 sites

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Shelby D. Rifkin, M.D.

    Arlington Heights, Illinois, 60004

  • Peachtree Hematology and Oncology

    Atlanta, Georgia, 40202

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • St. Agnes Healthcare, Inc.

    Baltimore, Maryland, 21229-5299

  • Southwestern Vermont Health Care

    Bennington, Vermont, 05201

  • Alabama Hematology/Oncology

    Birmingham, Alabama, 35243

  • Mid-Dakota Clinic PC

    Bismarck, North Dakota, 58501

  • Boca Raton Comprehensive Cancer Center

    Boca Raton, Florida, 33486

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence St. Joseph Medical Center

    Burbank, California, 91505

  • Nashat Gabrail, M.D.

    Canton, Ohio, 44718

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29403

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Carolina Medical Center

    Charlotte, North Carolina, 28203

  • The Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29201

  • Mid Ohio Oncology/Hematology, Inc.

    Columbus, Ohio, 43213

  • Hematology Oncology Consultants, Inc.

    Columbus, Ohio, 43235

  • Corpus Christi Cancer Center

    Corpus Christi, Texas, 78412

  • Center for Oncology Research & Treatment, PA

    Dallas, Texas, 75230

  • Danville Hematology and Oncology, Inc.

    Danville, Virginia, 24541

  • Colorado Cancer Research Program

    Denver, Colorado, 80224

  • Josephine Ford Cancer Center

    Detroit, Michigan, 48202

  • SMDC Health System

    Duluth, Minnesota, 55805

  • Western Washington Medical Group

    Everett, Washington, 98201

  • Western Washington Medical Group

    Everett, Washington, 982901

  • Northern Virginia Oncology Group

    Fairfax, Virginia, 22031

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Compassionate Cancer Care Medical Group, Inc

    Fountain Valley, California, 92708

  • California Oncology of the Central Valley

    Fresno, California, 93710

  • Virginia K. Crosson Cancer Center

    Fullerton, California, 92835

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Ronald Yanagiharaa, M.D.

    Gilroy, California, 95020

  • Palo Verde Hematology & Oncology

    Glendale, Arizona, 85304

  • Glendale Adventist Medical Center Cancer Center

    Glendale, California, 91206

  • CR Wood Cancer Center

    Glens Falls, New York, 12801

  • Spectrum Health -- Cook Research Dept.

    Grand Rapids, Michigan, 49503

  • North Central Montana Professional Building

    Great Falls, Montana, 59405

  • Cancer Research of Long Island

    Great Neck, New York, 11023

  • Cancer Center of the Carolinas

    Greenville, South Carolina, 29615

  • Monroe Medical Associates

    Harvey, Illinois, 60426

  • Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Oncology Consultants

    Houston, Texas, 77024

  • H. Alejandro Preti, MD, PA

    Houston, Texas, 77030

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Hematology-Oncology of Indiana, PC

    Indianapolis, Indiana, 46260

  • Dr. Lee C. Drinkard

    Irving, Texas, 75038

  • Hematology and Oncology Assoc. of Southern Mississippi

    Jackson, Michigan, 48201

  • Florida Oncology Associates

    Jacksonville, Florida, 32204

  • Broome Oncology

    Johnson City, New York, 13790

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Heartland Hematology/Oncology Associates, Inc.

    Kansas City, Missouri, 64118

  • Kansas City Oncology and Hematology Group

    Kansas City, Missouri, 64131

  • Cascade Cancer Center

    Kirkland, Washington, 98034

  • Baptist Regional Cancer Center

    Knoxville, Tennessee, 37920

  • Louisiana Oncology Associates

    Lafayette, Louisiana, 70506

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33803

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

  • New York Oncology Hematology

    Latham, New York, 12110

  • Markey Clinical Oncology Research Program

    Lexington, Kentucky, 40536-0098

  • St. Barnabas Cancer Center

    Livingston, New Jersey, 07039

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Cancer Institute Medical Group

    Los Angeles, California, 90025

  • USC/Norris Comprehensive Cancer Care Center

    Los Angeles, California, 90033

  • Synergy Hematology-Oncology Medical Associates

    Los Angeles, California, 90057

  • UCLA School of Medicine

    Los Angeles, California, 90095

  • Norton Healthcare Pavilion

    Louisville, Kentucky, 40202

  • Vijay Raghavan, M.D.

    Louisville, Kentucky, 40215

  • UW Health -- University of Wisconsin Comp

    Madison, Wisconsin, 53792

  • Davis, Posteraro and Wasser, MD's, LLP

    Manchester, Connecticut, 06040

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Meridia Cancer Institute

    Mayfield Heights, Ohio, 44124

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38104

  • Oncology Hematology Group of South Florida

    Miami, Florida, 33176

  • Innovative Medical Research of South Florida

    Miami Shores, Florida, 33138

  • Connecticut Oncology Group

    Middletown, Connecticut, 06457

  • Minnesota CGOP

    Minneapolis, Minnesota, 55407

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Montana Cancer Specialists

    Missoula, Montana, 59807-7877

  • Monogahela Valley Hospital

    Monongahela, Pennsylvania, 15063

  • Eddie Hong-Lung Hu, M.D.

    Monterey Park, California, 91754

  • Hematology-Oncology Associates of New Jersey

    Morristown, New Jersey, 07960

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • LSU Medical Center

    New Orleans, Louisiana, 70112

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Medical Oncology Hematology Consultants

    Newark, Delaware, 19808

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • North Valley Hematology/Oncology Medical Group

    Northridge, California, 91328

  • Cancer Center at Nyack Hospital

    Nyack, New York, 10960

  • North Utah Associates

    Ogden, Utah, 84403-3105

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73112

  • The Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • Oncology Hematology Associates of Central Illinois, PC

    Peoria, Illinois, 61602

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212-4772

  • Wilshire Oncology Medical Group

    Pomona, California, 91767

  • Hematology Oncology Associates of Treasure

    Port Saint Lucie, Florida, 34952

  • Sierra View District Hospital

    Porterville, California, 93257

  • Kaiser Permanente Oncology Hematology

    Portland, Oregon, 97227

  • Cancer Treatment Centers of America

    Portsmouth, Virginia, 23704

  • The Lucy Curci Cancer Center

    Rancho Mirage, California, 92270

  • Cancer Care Associates Medical Group, Inc.

    Redondo Beach, California, 90277

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Pluta Cancer Center

    Rochester, New York, 14623

  • Kaiser Permanente

    Rockville, Maryland, 20850

  • Missouri Cancer Care, PC

    Saint Charles, Missouri, 63301

  • Oncology Care Associates, PLLC

    Saint Joseph, Michigan, 49085

  • Metro Minnesota CCOP

    Saint Louis Park, Minnesota, 55426

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84124

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94904

  • Santa Clara Valley Medical Center

    San Jose, California, 95128

  • Sansum Santa Barbara Foundation Medical Clinic

    Santa Barbara, California, 93105

  • Santa Barbara Hematology Oncology Medical Group, Inc.

    Santa Barbara, California, 93105

  • New Mexico Cancer Care

    Santa Fe, New Mexico, 87505

  • Coastal Hematology & Oncology

    Savannah, Georgia, 31406

  • Maine Center for Cancer Medicine & Blood Disorders

    Scarborough, Maine, 04074

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71130-3932

  • Northshore Cancer Research Association

    Skokie, Illinois, 60076

  • Midwest Cancer Research Group

    Skokie, Illinois, 60077

  • Providence Cancer Center

    Southfield, Michigan, 48075

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Highlands Oncology Group

    Springdale, Arkansas, 72764

  • Saint Louis University

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Arch Medical Services Incorporated

    St Louis, Missouri, 63141

  • Scott & White Hospital

    Temple, Texas, 76508

  • Associated Physicians & Surgeons Clinic, L.L.C.

    Terre Haute, Indiana, 47804

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136-1929

  • Southern Oncology and Hematology Associates

    Vineland, New Jersey, 08360

  • San Diego Cancer Center Medical Group

    Vista, California, 92083

  • Cooper Cancer Institute

    Voorhees Township, New Jersey, 08043

  • Washington Oncology-Hematology Center

    Washington D.C., District of Columbia, 20016

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Jennifer Caskey, M.D.

    Wheat Ridge, Colorado, 08833

  • Florida Medical Clinic, PA

    Zephyrhills, Florida, 33542

Other trials in United States

Germany14 sites

  • Study site

    Augsburg, 86150

  • Study site

    Berlin, 13353

  • Study site

    Berlin, 14195

  • Study site

    Cologne, 50677

  • Study site

    Dessau, 6822

  • Study site

    Erlangen, 91054

  • Study site

    Eschweiler, 52249

  • Study site

    Essen, 45122

  • Study site

    Frankfurt, 60488

  • Study site

    Hanover, 30625

  • Study site

    Heidelberg, 69115

  • Study site

    Kiel, 24116

  • Study site

    Leipzig, 4103

  • Study site

    Magdeburg, 39002

Other trials in Germany

Italy8 sites

  • Study site

    Forlì, 47100

  • Study site

    Genova, 16132

  • Study site

    Milan, 20162

  • Study site

    Modena, 41100

  • Study site

    Roma, 135

  • Study site

    Roma, 144

  • Study site

    Rozzano, 20089

  • Study site

    Torino, 10126

Other trials in Italy

Brazil6 sites

  • Study site

    Porto Alegre, CeP 90 610-000

  • Study site

    Porto Alegre RS, 90020-090

  • Study site

    Salvador, BA 41825-010

  • Study site

    São Paulo, 05651-901

  • Study site

    São Paulo, S01232-910

  • Study site

    São Paulo, S01308-050

Other trials in Brazil

Spain6 sites

  • Study site

    Alicante, 3202

  • Study site

    Madrid, 28033

  • Study site

    Madrid, 28035

  • Study site

    Madrid, 28041

  • Study site

    Málaga, 29010

  • Study site

    Zaragoza, 50009

Other trials in Spain

Australia5 sites

  • Study site

    Adelaide, SA 5000

  • Study site

    Garran, ACT 2605

  • Study site

    Nedlands, WS 6009

  • Study site

    Wollongong, NSW 2500

  • Study site

    Woolloongabba, QLD 4102

Other trials in Australia

Belgium5 sites

  • Study site

    Anderlecht, 1070

  • Study site

    Antwerp, 2020

  • Study site

    Brussels, 1200

  • Study site

    Ghent, 9000

  • Study site

    Wilrijk, 2610

Other trials in Belgium

Switzerland5 sites

  • Study site

    Basel, 4031

  • Study site

    Bern, 3010

  • Study site

    Thun, 3600

  • Study site

    Zurich, 8027

  • Study site

    Zurich, 8091

Other trials in Switzerland

Canada4 sites

  • Study site

    Hamilton, Ontario

  • Study site

    Sainte-Foy, Quebec

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

  • Study site

    Toronto, Ontario

Other trials in Canada

Hungary4 sites

  • Study site

    Budapest, H-1032

  • Study site

    Budapest, H-1097

  • Study site

    Győr, H-9002

  • Study site

    Szeged, H-6725

Other trials in Hungary

Slovakia4 sites

  • Novartis Investigative Site

    Bratislava, 81250

  • Novartis Investigative Site

    Bratislava, 833 10

  • Novartis Investigative Site

    Košice, 041 90

  • Novartis Investigative Site

    Žilina, 012 07

Other trials in Slovakia

Czechia3 sites

  • Study site

    Brno, 656 53

  • Study site

    Prague, 128 08

  • Study site

    Prague, 150 18

Other trials in Czechia

France3 sites

  • Study site

    Marseille, 13273

  • Study site

    Marseille, 13385

  • Study site

    Strasbourg, 6700

Other trials in France

Taiwan3 sites

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

United Kingdom3 sites

  • Study site

    Belfast, BT9 7AB

  • Study site

    Leicester, LE1 5WW

  • Study site

    Oxford, OX3 7LJ

Other trials in United Kingdom

New Zealand2 sites

  • Novartis Investigative Site

    Hamilton

  • Study site

    Palmerston North

Other trials in New Zealand

Netherlands1 site

  • Study site

    GA Utrecht, 3508

Other trials in Netherlands

Portugal1 site

  • Study site

    Coimbra, 3000-076

Other trials in Portugal

Sweden1 site

  • Study site

    Stockholm, SE-118 83

Other trials in Sweden

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo

To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment

Being tested
Vatalanib
Keywords
Colorectal Cancer, PTK787, Vatalanib, VEGF inhibitor, Oxaliplatin, Angiogenesis, Rectal Cancer, Colon Cancer, Colorectal Carcinoma, Colorectal Tumor
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.

  • VatalanibDrug

    Also called PTK787/ZK 222584

Study groups in NCT00056459
Study groupRoleWhat they receive
1ExperimentalOxaliplatin/5-FU/LV and PTK787/ZK 222584
Receives: Drug: Vatalanib
2Placebo comparatorOxaliplatin/5-FU/LV and placebo
Receives: Drug: Vatalanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Measured: Throughout duration of study

Secondary outcomes (4)

  1. Time to progression

    Measured: Throughout duration of study

  2. Time to treatment failure

    Measured: Throughout duration of study

  3. Best overall response rate

    Measured: Throughout duration of study

  4. Tolerability and safety profile

    Measured: Throughout duration of study

Timeline

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

  1. First posted14 Mar 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionJan 2007

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
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00056459
Sponsor's protocol ID
CPTK787 0135/306241
Other IDs
CONFIRM 1
Status last verified
Feb 2020
First submitted
13 Mar 2003
Last updated
10 Feb 2020
Results posted
No

Publications

  • Hecht JR, Trarbach T, Hainsworth JD, Major P, Jager E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4.

    PubMed 21464406

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vatalanib in people with Colorectal Neoplasms and Colonic Neoplasms, run by Novartis at 223 sites in 19 countries.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in United States, Germany, Italy, Brazil, Spain and 14 more countries. 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. Some participants in this study may receive a placebo. 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.

What does the primary outcome measure?

Progression free survival (time frame: Throughout duration of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00056459, 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 10 Feb 2020.

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