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

NCT00062426 | Completed Phase 3

• 3 other identifiers: CDR0000304771PROLOGUE-SANOFI-ARD5099SANOFI-ARD5099
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 52

Brief 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. 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.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; adenocarcinoma of the rectum; recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Interventions

bevacizumab BIOLOGICAL

capecitabine DRUG

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Prologue Research International: lead

Study Sites (52)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904-2007, United States

Location

Valley Tumor Medical Group

Lancaster, California, 93534, United States

Location

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Rocky Mountain Cancer Centers - Midtown

Denver, Colorado, 80218, United States

Location

Northwestern Connecticut Oncology-Hematology Associates

Torrington, Connecticut, 06790, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Lynn Regional Cancer Center West

Boca Raton, Florida, 33428, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Florida Oncology Associates

Jacksonville, Florida, 32207, United States

Location

Hematology and Oncology Consultants, P.A.

Orlando, Florida, 32804, United States

Location

Hematology Oncology Associates of theTreasure Coast - Port St. Lucie

Port Saint Lucie, Florida, 34952, United States

Location

Palm Beach Cancer Institute

West Palm Beach, Florida, 33401, United States

Location

Peachtree Hematology and Oncology Consultants, P.C.

Atlanta, Georgia, 30309, United States

Location

North Idaho Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068-1270, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, 21204, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

Deaconess Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Cooper Cancer Institute at Cooper University Hospital

Voorhees Township, New Jersey, 08043, United States

Location

Advanced Oncology Associates

Armonk, New York, 10504, United States

Location

North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, 11733, United States

Location

Arena Oncology Associates

Great Neck, New York, 11021, United States

Location

St. Vincents Comprehensive Cancer Center

New York, New York, 10011, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

Physicians East - Quadrangle

Greenville, North Carolina, 27834, United States

Location

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

Raleigh, North Carolina, 27609-7300, United States

Location

Hematology Oncology Consultants Inc

Columbus, Ohio, 43235, United States

Location

Hematology/Oncology of Salem

Salem, Oregon, 97301, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Charleston Hematology-Oncology, P.A.

Charleston, South Carolina, 29403, United States

Location

McCleod Cancer and Blood Center

Johnson City, Tennessee, 37604, United States

Location

Memphis Cancer Center

Memphis, Tennessee, 38119, United States

Location

West Clinic

Memphis, Tennessee, 38120, United States

Location

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Lone Star Oncology

Austin, Texas, 78759, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

South Texas Oncology and Hematology

San Antonio, Texas, 78207, United States

Location

Center for Cancer Prevention and Care at Scott and White Clinic

Temple, Texas, 76508, United States

Location

Medical Consultants

Milwaukee, Wisconsin, 53215-3690, United States

Location

Related Publications (1)

• 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.

  PMID: 21245868 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Richard A. Gams, MD

  Prologue Research International

  STUDY CHAIR

• Lauri Welles, MD

  Sanofi-Synthelabo

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: May 1, 2003
• Study Completion: February 1, 2011
• Last Updated: November 6, 2013

Record last verified: 2004-04

Locations

US (52)