Know Cancer

forgot password

Phase II Trial of Fluorouracil (5-FU), Leucovorin (LV), Irinotecan (CPT-11) and Bevacizumab (Anti-VEGF) in Previously Untreated Patients With Advanced Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Phase II Trial of Fluorouracil (5-FU), Leucovorin (LV), Irinotecan (CPT-11) and Bevacizumab (Anti-VEGF) in Previously Untreated Patients With Advanced Colorectal Cancer

OBJECTIVES: I. Determine the progression-free survival at 7 months of patients with
previously untreated advanced colorectal cancer treated with fluorouracil, leucovorin
calcium, irinotecan, and bevacizumab. II. Determine the response rate and overall survival
of this patient population treated with this regimen. III. Determine the toxicity of this
treatment regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes,
leucovorin calcium IV, and fluorouracil IV once weekly for 4 weeks. Patients also receive
bevacizumab IV over 30-90 minutes once every 2 weeks. Treatment repeats every 6 weeks in the
absence of disease progression or unacceptable toxicity. Patients are followed every 3
months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic adenocarcinoma of
the colon and rectum Surgically unresectable disease Measurable disease Disease outside
the prior radiotherapy port and/or progressive disease within the previously irradiated

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No
hemorrhagic events within the past 6 months Hepatic: Bilirubin normal SGOT normal INR no
greater than 1.5 Renal: Creatinine no greater than 1.5 times upper limit of normal
Cardiovascular: No thromboembolic events within the past 6 months Pulmonary: No evidence
of pneumonia Other: No known hypersensitivity to recombinant humanized murine monoclonal
antibodies No evidence of significant active infection (e.g., peritonitis or wound
abscess) Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF)
Chemotherapy: At least 12 months since prior fluorouracil-based adjuvant chemotherapy No
prior adjuvant irinotecan Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics At least 2 weeks since prior radiotherapy and recovered Surgery: See
Disease Characteristics Other: No prior therapy for advanced disease No concurrent
therapeutic anticoagulation except for low-dose coumadin for maintenance of indwelling

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Bruce J. Giantonio, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Presbyterian Medical Center


United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

September 2006

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Stanford University Medical Center Stanford, California  94305-5408
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Rochester Cancer Center Rochester, New York  14642
Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc. Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
New England Medical Center Hospital Boston, Massachusetts  02111
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
CCOP - Duluth Duluth, Minnesota  55805
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Medical College of Wisconsin Milwaukee, Wisconsin  53226
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Albany Albany, New York  12208
CCOP - Columbus Columbus, Ohio  43206
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
Veterans Affairs Medical Center - Cleveland Cleveland, Ohio  44106
Veterans Affairs Medical Center - Nashville Nashville, Tennessee  37212
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
CCOP - Sooner State Tulsa, Oklahoma  74136
MBCCOP-Howard University Cancer Center Washington, District of Columbia  20060
MBCCOP-Our Lady of Mercy Cancer Center Bronx, New York  10466
Veterans Affairs Medical Center - Gainsville Gainesville, Florida  32608-1197
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105
University of Pennsylvania Health Systems Philadelphia, Pennsylvania  19104-9104