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A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

Phase 3
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum


- Compare the time to progression in patients with locally advanced, locally recurrent,
or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin,
fluorouracil, leucovorin calcium, and irinotecan.

- Compare the quality of life, response rate, time to treatment failure, and overall
survival in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG
performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy
(yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three
treatment arms.

Only arm II remains open to accrual.

- Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by
leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks
followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as
of March 15, 2002.)

- Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and
leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2.
Courses repeat every 2 weeks.

- Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and
irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed
to accrual as of March 15, 2002.) Treatment continues in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed before treatment, during treatment (arm specific), and after
completion of treatment.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study
thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual
as of March 15, 2002.)

Inclusion Criteria


- Histologically or cytologically confirmed locally advanced, locally recurrent, or
metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy

- Histological or cytological requirement waived in patients who developed
radiological or clinical evidence of metastatic cancer after a prior surgical
resection unless:

- More than 5 years has elapsed since primary surgery OR

- Primary cancer was stage I or II

- Site of primary lesion must be or have been confirmed endoscopically, radiologically,
or surgically to be or have been in the large bowel

- Measurable or evaluable disease

- No CNS metastases or carcinomatous meningitis



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL (transfusion allowed)


- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 5 times ULN


- Creatinine no greater than 1.5 times ULN


- No uncontrolled hypertension

- No unstable angina

- No symptomatic congestive heart failure

- No myocardial infarction within the past 6 months

- No serious uncontrolled arrhythmia

- No New York Heart Association class III or IV cardiac disease


- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the

- No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active or uncontrolled infection

- No symptomatic sensory peripheral neuropathy

- No known allergy to platinum compounds

- No history of gastrointestinal bleeding unless it is determined to be acceptable by
the enrolling physician

- No other prior or concurrent malignancy within the past 3 years except nonmelanoma
skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant
tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis

- No medical or psychiatric conditions that would preclude study

- No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose
stools per day

- Colostomy or ileostomy allowed at investigator's discretion


Biologic therapy:

- Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant
therapy concluded at least 1 year before documentation of recurrent disease

- No concurrent sargramostim (GM-CSF)


- No prior chemotherapy for advanced colorectal cancer

- No prior standard adjuvant chemotherapy for rectal cancer

- Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant
therapy concluded at least 1 year before documentation of recurrent disease

Endocrine therapy:

- Not specified


- See Disease Characteristics

- At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative

- No prior radiotherapy to more than 15% of bone marrow

- No prior standard adjuvant radiotherapy for rectal cancer


- See Disease Characteristics

- At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor
surgery) and recovered

- Insertion of a vascular access device not considered major or minor surgery


- No other concurrent investigational agents

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Henry C. Pitot, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

Related Keywords:

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



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Chao Family Comprehensive Cancer Center Orange, California  92868
Stanford University Medical Center Stanford, California  94305-5408
University of Colorado Cancer Center Denver, Colorado  80262
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
University of Chicago Cancer Research Center Chicago, Illinois  60637
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
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Bronson Methodist Hospital Kalamazoo, Michigan  49007
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St. John Macomb Hospital Warren, Michigan  48093
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Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
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NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
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Huntsman Cancer Institute Salt Lake City, Utah  84112
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Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
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University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
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Baptist Regional Cancer Institute - Jacksonville Jacksonville, Florida  32207
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Virginia Piper Cancer Institute Minneapolis, Minnesota  55407
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
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Sioux Valley Hospital Sioux Falls, South Dakota  57117
Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Creighton University Cancer Center Omaha, Nebraska  68131-2197
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Chester County Hospital West Chester, Pennsylvania  19380
Oncology Institute of Greater Lafayette Lafayette, Indiana  47904
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
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Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
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St. Mary-Corwin Regional Medical Center Pueblo, Colorado  81004
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Mercy Hospital and Medical Center Chicago, Illinois  60616
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Galesburg Clinic Galesburg, Illinois  61401
InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Kewanee Hospital Kewanee, Illinois  61443
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BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Valley Cancer Center Spring Valley, Illinois  61362
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Burgess Health Center Onawa, Iowa  51040
Community Cancer Center of Monroe Monroe, Michigan  48162
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St. Joseph's Medical Center Brainerd, Minnesota  56401
St. Elizabeth Regional Medical Center Lincoln, Nebraska  68510
Bismarck Cancer Center Bismarck, North Dakota  58501
St. Alexius Medical Center Bismarck, North Dakota  58502
Wood County Oncology Center Bowling Green, Ohio  43402
Fremont Memorial Hospital Fremont, Ohio  43420
Lima Memorial Hospital Lima, Ohio  45804
Firelands Regional Medical Center Sandusky, Ohio  44870
Fulton County Health Center Wauseon, Ohio  43567
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105
Illinois Oncology Research Association Peoria, Illinois  61602
North Memorial Research Center Minneapolis, Minnesota  55442-2900
University of Florida - Gainesville Gainesville, Florida  32610-0277
Eureka Hospital Eureka, Illinois  61530
Mercy Hospital Coon Rapids, Minnesota  55433
Park Nicollet Clinic St. Louis Park, Minnesota  55416
Mayo Clinic Hospital Phoenix, Arizona  85054-4502
Community Hospital of the Monterey Peninsula Monterey, California  93940
Columbia Medical Center of Aurora North Campus Aurora, Colorado  80011
Penrose Cancer Center Colorado Springs, Colorado  80933
HealthOne Rose Medical Center Denver, Colorado  80220
Rocky Mountain Cancer Centers - Northern Colorado Fort Collins, Colorado  80524-4038
Poudre Valley Radiation Oncology Fort Collins, Colorado  80528
Bristol Hospital Bristol, Connecticut  06011-0977
Lawrence and Memorial Hospital New London, Connecticut  06320
William W. Backus Hospital Norwich, Connecticut  06360
Northwestern Connecticut Oncology-Hematology Associates Torrington, Connecticut  06790
University of Florida Health Science Center - Jacksonville Jacksonville, Florida  32209
Grady Memorial Hospital Atlanta, Georgia  30335
BroMenn Lifecare Center Bloomington, Illinois  61701-3081
St. Joseph's Hospital Medical Center Bloomington, Illinois  61701
Graham Hospital Association Canton, Illinois  61520
Hematology-Oncology Associates of Illinois Chicago, Illinois  60611-2998
Hematology Oncology Associates of Illinois - Lake Shore Dr Chicago, Illinois  60611
Holy Family Medical Center Des Plaines, Illinois  60016
St. Anthony's Memorial Hospital Effingham, Illinois  62401
Northwest Oncology and Hematology, S.C. Elk Grove Village, Illinois  60007
Glenbrook Hospital Glenview, Illinois  60025
Hematology Oncology Associates of Illinois-Highland Park Highland Park, Illinois  60035
Hopedale Medical Complex Hospital Hopedale, Illinois  61747
Joliet Oncology/Hematology Associates, Ltd. Joliet, Illinois  60435
Silver Cross Hospital Joliet, Illinois  60432
Saint Joseph Medical Center Joliet, Illinois  60435
Deerpath Medical Associates Lake Forest, Illinois  60045
North Shore Oncology Hematology Associates Libertyville, Illinois  60048
Hematology/Oncology Associates of Illinois, LLC Melrose Park, Illinois  60160
Mendota Community Hospital Mendota, Illinois  61342
Trinity Medical Center Moline, Illinois  61265-1291
Morris Hospital Morris, Illinois  60450
Hematology Oncology Associates of Illinois, LLC Oak Park, Illinois  60304
Pekin Hospital Pekin, Illinois  61554
Midwest Radiation Oncology Physicians Peoria, Illinois  61636
Peoria Urological Associates Peoria, Illinois  61614
Midwest Urological Group Peoria, Illinois  61603
Affiliated Urology Specialists Peoria, Illinois  61603
St. Francis Medical Center Peoria, Illinois  61637
St. James Hospital Pontiac, Illinois  61764
Swedish-American Health System Rockford, Illinois  61104-2315
Sarah D. Culbertson Memorial Hospital Rushville, Illinois  62681
Midwest Cancer Research Group, Inc. Skokie, Illinois  60077
Edward H. Kaplan MD and Associates Skokie, Illinois  60076
Carle Foundation Hospital Urbana, Illinois  61801
Carle Cancer Center Urbana, Illinois  61801
Therapy Associates Hematology/Oncology Evansville, Indiana  47715
William R. Bliss Cancer Center Ames, Iowa  50010
McFarland Clinic, P.C. Ames, Iowa  50010
Saint Anthony Regional Hospital Carroll, Iowa  51401
Alegent Health Southwest Iowa Medical Center Council Bluffs, Iowa  51503
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Mercy Hospital Medical Center Des Moines, Iowa  50314
Des Moines General Hospital Des Moines, Iowa  50309
Mercy Cancer Center Mason City, Iowa  50401
Community Memorial Hospital Missouri Valley, Iowa  51555-1199
Ottumwa Regional Health Center Ottumwa, Iowa  52501
Oncology & Hematology of Ottumwa, PC Ottumwa, Iowa  52501
Cancer Center of Kansas - Arkansas City Arkansas City, Kansas  67005
Radiation Oncology Center Dodge City, Kansas  67801
Halstead Cancer Center of Kansas Halstead, Kansas  67056
Liberal Cancer Center of Kansas Liberal, Kansas  67901
Wichita Clinic Cancer Medicine Associates, P.A. Wichita, Kansas  67208
Associates in Women's Health - Wichita Wichita, Kansas  67208
Cancer Center of Kansas - Wichita Wichita, Kansas  67214
Anne Arundel Medical Center Annapolis, Maryland  21401
Faulkner Hospital Jamaica Plain, Massachusetts  02130
Lawrence Memorial Hospital of Medford/Hallmark Health Systems Medford, Massachusetts  02155
Morton Hospital & Medical Center Taunton, Massachusetts  02780
Bixby Medical Center Adrian, Michigan  49221
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Genesee Regional Medical Center Flint, Michigan  48503
Office of E. Michael Lodish Madison Heights, Michigan  48071-3457
Balcueva Clinic Saginaw, Michigan  48602
Alexandria Clinic Alexandria, Minnesota  56308
Alexandria Radiation Oncology Alexandria, Minnesota  56308
Miller-Dwan Medical Center Duluth, Minnesota  55805
Fairview-Southdale Hospital Edina, Minnesota  55435
Fergus Falls Medical Group Fergus Falls, Minnesota  56537
Mercy/Unity Hospitals Fridley, Minnesota  55432
Duluth Clinic - Hibbing Hibbing, Minnesota  55746
Central Mesabi Medical Center Hibbing, Minnesota  55746
Radiation Therapy Center Hibbing, Minnesota  55746
St. John's Hospital Maplewood, Minnesota  55109
Fairview University Medical Center - Riverside Campus Minneapolis, Minnesota  55454-1395
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
St. Cloud Hospital Saint Cloud, Minnesota  56303
Regions Hospital Saint Paul, Minnesota  55101
Healtheast Cancer Care Saint Paul, Minnesota  55102
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Rice Memorial Hospital Willmar, Minnesota  56201
Fremont Area Medical Center Fremont, Nebraska  68025-2387
Williamsburg Radiation Oncology Center Lincoln, Nebraska  68516
Bryan LGH Medical Center Lincoln, Nebraska  68502-3780
Bryan LGH Medical Center East Lincoln, Nebraska  68506
Office of Susan Hansen, M.D. Lincoln, Nebraska  68506
Prairie View Clinic Lincoln, Nebraska  68506-5247
Southeast Nebraska Hematology Lincoln, Nebraska  68516
Southeast Nebreska Hematology-Oncology Consultants, PC Lincoln, Nebraska  68516
Wedgewood Medical Center Lincoln, Nebraska  68510
Alegent Health - Immanuel Medical Center Omaha, Nebraska  68122
St. Joseph Hospital Omaha, Nebraska  68131-2197
Oncology Hematology West, P.C. Omaha, Nebraska  68114
Center for Cancer And Hematologic Disease Cherry Hill, New Jersey  08046
Southern Oncology-Hematology Associates, P.A. Vineland, New Jersey  08360
Comprehensive Cancer and Hematology Associates Voorhees, New Jersey  08043
Burlington County Hematology Oncology Association, P.A. Willingboro, New Jersey  08046
Mary Imogene Bassett Hospital Cooperstown, New York  13326
Mid Dakota Clinic, P.C. Bismarck, North Dakota  58501
Altru Cancer Center Grand Forks, North Dakota  58206
Mercy Ireland Cancer Center Canton, Ohio  44708
Woman Wise Blanchard Valley Regional Health Center Findlay, Ohio  45840
Office of Sharon Cole, M.D. Kenton, Ohio  43326
Saint Luke's Hospital Maumee, Ohio  43537
North West Ohio Oncology Center Maumee, Ohio  43537
St. Charles Hospital Oregon, Ohio  43616
North Coast Cancer Care, Inc. Sandusky, Ohio  44870
Flower Hospital - Pro Medica Health System Sylvania, Ohio  43560
Haematology-Oncology Associates, Inc. Toledo, Ohio  43623-4474
Riverside Hospital Toledo, Ohio  43604
Toledo Clinic, Inc. Toledo, Ohio  43623
MCO Cancer Institute Toledo, Ohio  43614
Medical College of Ohio Hospital Toledo, Ohio  43614-0008
Muhlenberg Hospital Center Bethlehem, Pennsylvania  18017
Marion Community Hospital Carbondale, Pennsylvania  18407
DuBois Regional Medical Center DuBois, Pennsylvania  15801-0447
UPMC Horizon Greenville, Pennsylvania  16125
Pinnacle Health Hospitals Harrisburg, Pennsylvania  17105-8700
Wayne Memorial Hospital Honesdale, Pennsylvania  18431-1498
Conemaugh Memorial Hospital Johnstown, Pennsylvania  15905
UPCI @ UPMC Lee Hospital Johnstown, Pennsylvania  15901
Armstrong County Memorial Hospital Kittanning, Pennsylvania  16201-8808
Lancaster General Hospital Lancaster, Pennsylvania  17604-3555
Latrobe Area Hospital Latrobe, Pennsylvania  15650
Central Pennsylvania Hematology and Medical Oncology Associates Lemoyne, Pennsylvania  17043
Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
UPMC/Passavant Hospital Pittsburgh, Pennsylvania  15237
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
Pottstown Memorial Regional Cancer Center Pottstown, Pennsylvania  19464
Scranton Hematology-Oncology Scranton, Pennsylvania  18510
Moses Taylor Hospital Scranton, Pennsylvania  18510
Geisinger Medical Group State College, Pennsylvania  16801
Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Sioux Valley Clinic Sioux Falls, South Dakota  57104
Fox Valley Hematology and Oncology Appleton, Wisconsin  54911
Memorial Medical Center Ashland, Wisconsin  54806
Luther Hospital Eau Claire, Wisconsin  54703
Midelfort Clinic Eau Claire, Wisconsin  54703
Franciscan Skemp Healthcare La Crosse, Wisconsin  54601-4796
Dean Medical Center Madison, Wisconsin  53715
Aurora Sinai Samaritan Medical Center Milwaukee, Wisconsin  53201-0342
Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
UW Cancer Center Wausau Hospital Wausau, Wisconsin  54401