Colon Cancer Clinical Trial

Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the best treatment.

PURPOSE: This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating patients with metastatic or recurrent colorectal cancer.

View Full Description

Full Description

OBJECTIVES:

Compare the response rate (complete and partial), progression-free survival, and overall survival of patients with previously untreated metastatic or locally recurrent colorectal adenocarcinoma with high vs low thymidylate synthase (TS) expression treated with fluorouracil, leucovorin calcium, oxaliplatin, and bevacizumab or irinotecan, oxaliplatin, and bevacizumab.
Compare the toxicity of these regimens in these patients.
Correlate gene expression with response rates in patients treated with these regimens.
Correlate gene expression with toxicity of these regimens in these patients.
Correlate dihydropyrimidine dehydrogenase, thymidine phosphorylase, and mammalian excision repair cross complementary protein expression with antitumor response in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to thymidylate synthase (TS) expression levels (high vs low or indeterminate). Patients with high TS expression are randomized to 1 of 2 treatment arms (Arms A or B). Patients with low or indeterminate TS expression are assigned to Arm C.

Arm A: Patients receive bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15.
Arm B: Patients receive bevacizumab and oxaliplatin as in arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.
Arm C: Patients receive bevacizumab, oxaliplatin, leucovorin calcium, and fluorouracil as in arm B.

In all arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Patients are followed up every 3 months for 2 years and then every 6 months for 2 years from the date of study registration.

View Eligibility Criteria

Eligibility Criteria

INCLUSION:

Metastatic or locally recurrent colorectal adenocarcinoma
Measurable disease
At least 2 formalin-fixed paraffin embedded core needle biopsies OR fine needle aspirate containing a minimum of 3 clusters of malignant cells and fixed tissue from the previous biopsy
If no tissue samples are available the patient must be willing to undergo biopsy of a metastatic site
Age 18 and over
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 unless patient is receiving full-dose anticoagulants AND the following criteria are met:

In-range INR (usually between 2 and 3) AND on a stable dose of warfarin or low molecular weight heparin
No active bleeding or pathological condition that is associated with a high risk of bleeding
Partial thromboplastin time (PTT) < 1.5 times upper limit of normal (ULN)
Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 3 times ULN
Bilirubin ≤ 1.5 times ULN
Creatinine ≤ 1.8 mg/dL

Meets 1 of the following criteria:

Protein negative on urine dipstick
Urine protein/creatinine ratio < 1.0
Less than 2 g protein on 24-hour urine collection

Patients with a history of hypertension must meet the following criteria:

Blood pressure < 150/90 mm Hg
Stable regimen of anti-hypertensive therapy
More than 28 days since prior major or open surgery
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation

Prior non-colorectal malignancies are allowed provided the following criteria are met:

No current clinical evidence of persistent or recurrent disease
No active therapy for non-colorectal malignancy, including hormonal therapy

EXCLUSION:

Pregnant or nursing

Arterial thromboembolic events within the past 6 months, including the following:

Transient ischemic attack
Cerebrovascular accident
Unstable angina pectoris
Myocardial infarction
Symptomatic arrhythmia
Symptomatic congestive heart failure
Clinically significant peripheral artery disease
New York Heart Association class III or IV heart disease
Serious nonhealing wound, ulcer, or bone fracture within the past 28 days
Significant traumatic injury within the past 28 days
Neuropathy ≥ grade 2
Ongoing or active infection
Concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Prior chemotherapy for metastatic disease. Adjuvant therapy completed at least 12 months before first evidence of metastasis allowed
Cardiovascular, renal, hepatic, or other nonmalignant systemic disease that would preclude study therapy

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

247

Study ID:

NCT00098787

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 98 Locations for this study

See Locations Near You

California Cancer Care, Incorporated - Greenbrae
Greenbrae California, 94904, United States
Aurora Presbyterian Hospital
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
St. Anthony Central Hospital
Denver Colorado, 80204, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction Colorado, 81502, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
Littleton Adventist Hospital
Littleton Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80501, United States
McKee Medical Center
Loveland Colorado, 80539, United States
Parker Adventist Hospital
Parker Colorado, 80138, United States
St. Mary - Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge Colorado, 80033, United States
University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Saint Joseph Hospital
Chicago Illinois, 60657, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee Illinois, 60901, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville Illinois, 60048, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles Illinois, 60714, United States
Swedish-American Regional Cancer Center
Rockford Illinois, 61104, United States
Hematology Oncology Associates - Skokie
Skokie Illinois, 60076, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis
Indianapolis Indiana, 46202, United States
William N. Wishard Memorial Hospital
Indianapolis Indiana, 46202, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Joseph Regional Medical Center
Mishawaka Indiana, 46545, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
McCreery Cancer Center at Ottumwa Regional
Ottumwa Iowa, 52501, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51102, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph Michigan, 49085, United States
MeritCare Bemidji
Bemidji Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Minnesota Oncology - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology - Woodbury
Woodbury Minnesota, 55125, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Lakeside Hospital
Omaha Nebraska, 68130, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton New Jersey, 08053, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
Roger Maris Cancer Center at MeritCare Hospital
Fargo North Dakota, 58122, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
St. Rita's Medical Center
Lima Ohio, 45801, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Knox Community Hospital
Mount Vernon Ohio, 43050, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
Southern Ohio Medical Center Cancer Center
Portsmouth Ohio, 45662, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma, 74136, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown Pennsylvania, 18105, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Cancer Center of Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
CCOP - Main Line Health
Wynnewood Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga Tennessee, 37403, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

247

Study ID:

NCT00098787

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.