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Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
irinotecan hydrochloride
oxaliplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum Metastatic or recurrent disease that is not amenable to potentially curative treatment Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% 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 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No New York Heart Association class III or IV congestive heart failure No serious cardiac arrhythmia No history of cardiac toxicity from fluorouracil/leucovorin calcium No myocardial infarction within past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No uncontrolled predisposing colonic or small bowel disorder No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction No diabetes No active infection No known current peripheral neuropathy No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No intolerance of appropriate antiemetics No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No prior irinotecan or oxaliplatin No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to non-target lesions allowed No prior radiotherapy to target lesions unless disease progression is documented within the radiation port At least 3 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgical procedure and recovered Prior surgery for primary tumor or metastasis allowed Other: At least 30 days since prior investigational drug No concurrent investigational agents

Sites / Locations

  • Comprehensive Cancer Institute of Huntsville
  • Oncology Center at Providence Park
  • Arizona Clinical Research Center
  • Citrus Valley Medical Center
  • California Cancer Care, Inc.
  • Tower Hematology Oncology Medical Group
  • Kenmar Research Institute
  • Medical Oncology Care Associates
  • P.M.K. Medical Group, Inc.
  • Cancer and Blood Institute of the Desert
  • Kaiser Permanente-Southern California Permanente Medical Group
  • John Wayne Cancer Institute
  • Kaiser Permanente Medical Center - Vallejo
  • Colorado Permanente Medical Group, P.C.
  • Rocky Mountain Cancer Center
  • University of Colorado Cancer Center
  • Whittingham Cancer Center
  • George Washington University Medical Center
  • Comprehensive Cancer Care Specialists of Boca Raton
  • Center for Hematology-Oncology
  • Southeast Florida Hematology-Oncology Group
  • Florida Cancer Specialists
  • Shands Hospital and Clinics, University of Florida
  • Hematology and Oncology Associates of Jacksonville
  • University of Florida Health Science Center - Jacksonville
  • Lakeland Regional Medical Center
  • Lake Heart and Cancer Medical Center
  • Oncology-Hematology Group of South Florida
  • Hematology and Oncology Consultants, P.A.
  • Hematology/Oncology Associates
  • Oncology & Hematology Associates of West Broward
  • University Community Hospital
  • Hematology and Oncology Consultants
  • North Idaho Cancer Center
  • Northwest Medical Specialists, P.C.
  • Dreyer Medical Clinic
  • Northwestern Medical Faculty Foundation
  • Cancer Care Center
  • Albert B. Chandler Medical Center, University of Kentucky
  • James Graham Brown Cancer Center
  • Kentuckiana Cancer Institute
  • Norton Healthcare Pavilion
  • Veterans Affairs Medical Center - Louisville
  • Baton Rouge General Medical Center
  • Louisiana Oncology Associates
  • Doctors Hospital of Jefferson
  • Stanley Scott Cancer Center
  • Greater Baltimore Medical Center and Cancer Center
  • Medical Center of Boston
  • Berkshire Hematology Oncology, P.C.
  • Barbara Ann Karmanos Cancer Institute
  • Parker Hughes Cancer Center
  • Jackson Oncology Associates, PLLC
  • Veterans Affairs Medical Center - Kansas City
  • Siteman Cancer Center
  • St. John's Mercy Medical Center
  • Missouri Cancer Care, P.C.
  • Great Falls Clinic
  • Western Montana Clinic
  • Somerset Medical Center
  • Cooper Cancer Institute
  • Veterans Affairs Medical Center - Albany
  • Montefiore Medical Center
  • Queens Medical Associates, PC
  • Queens Hospital Center
  • Interlakes Oncology/Hematology PC
  • New York Medical College
  • Lineberger Comprehensive Cancer Center, UNC
  • Raleigh Hematology/Oncology Associates - Wake Practice
  • Piedmont Hematology-Oncology Associates
  • Cleveland Clinic Taussig Cancer Center
  • Hematology Oncology Consultants Inc
  • Bend Memorial Clinic
  • Kaiser Permanente - Portland
  • Pinnacle Health Hospitals
  • Abington Hematology Oncology Associates, Incorporated
  • University of Pennsylvania Cancer Center
  • Pennsylvania Oncology Hematology Associates
  • University of Pittsburgh Cancer Institute
  • Lifespan: The Miriam Hospital
  • Physicians East - Quadrangle
  • Cancer Centers of the Carolinas
  • Erlanger Health Systems
  • Baptist Regional Cancer Center - Knoxville
  • West Clinic
  • Memphis Cancer Center
  • Tennessee Oncology, P.L.L.C.
  • Vanderbilt-Ingram Cancer Center
  • Lone Star Oncology
  • Center for Oncology Research and Treatment, Medical City Hospital
  • Baptist Health System Cancer Program
  • Huntsman Cancer Institute
  • Cancer Center at the University of Virginia
  • Hematology-Oncology Associates of Frederiksburg, Inc.
  • Virginia Mason Medical Center
  • Advanced Health Care
  • UW Cancer Center Wausau Hospital
  • Irving Cancer Center
  • Porto Alegre Hospital
  • Instituto de Oncologia de Soracaba
  • Hospital Joao Alves Fiho
  • Hospital Socor
  • Hospital Erastos Gaertner
  • Instituto Nacional de Cancer
  • Oncologistas Associados
  • Hospital do Cancer A C Comargo
  • Tom Baker Cancer Center - Calgary
  • University of Alberta
  • Nova Scotia Cancer Centre
  • Royal Victoria Hospital, Barrie
  • Cancer Care Ontario-London Regional Cancer Centre
  • Ottawa Regional Cancer Centre
  • Northeastern Ontario Regional Cancer Centre, Sudbury
  • Toronto Sunnybrook Regional Cancer Centre
  • Mount Sinai Hospital - Toronto
  • Princess Margaret Hospital
  • Hopital Charles Lemoyne
  • Cite de la Sante de Laval
  • L'Hotel Dieu de Levis
  • Maisonneuve-Rosemont Hospital
  • Jewish General Hospital - Montreal
  • Hopital Du Sacre-Coeur de Montreal
  • Centre Hospitalier Universitaire de Quebec
  • Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL
  • L'Hopital Laval
  • Saskatoon Cancer Centre
  • Zoom International Incoporated
  • Centre of Clinical Oncology and Radiation Oncology
  • Charles University Hospital
  • Onkologicka Klinka A Onkologicka Lab
  • Fakultni Nemocnice V Motole
  • Semmelweis University
  • National Institute of Oncology
  • Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
  • Szent Laszlo Korhaz
  • Kozponti Honvedkorhaz I. Belgyogyaszat
  • Debreceni Egyetem Onkologiai Tanzek
  • Petz Aladar County Hospital
  • Maria S. Curie Memorial Institute
  • Jagiellonian University
  • Institute of Oncology
  • Wielkopolskie Centrum Onkologii Oddzial Chemioterapii
  • St. Luke's Cancer Center
  • St. Bartholomew's Hospital
  • Guy's and St. Thomas' Hospitals NHS Trust
  • Charing Cross Hospital
  • Maidstone Hospital
  • Christie Hospital N.H.S. Trust
  • Derriford Hospital
  • Weston Park Hospital
  • Royal Marsden Hospital
  • Aberdeen Royal Infirmary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 3, 2001
Last Updated
December 18, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00012389
Brief Title
Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Official Title
A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2002
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
Detailed Description
OBJECTIVES: Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin. Compare the response rate, time to tumor-related worsening of symptoms, time to disease progression, onset and duration of responses, and duration of disease stabilization in these patients treated with these regimens. Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive irinotecan IV over 90 minutes on day 1. Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over 30 minutes on day 1. Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study within 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum Metastatic or recurrent disease that is not amenable to potentially curative treatment Progressive or recurrent disease during or after 1, and only 1, regimen of fluorouracil with or without leucovorin calcium or during or within 6 months after adjuvant chemotherapy with fluorouracil and leucovorin calcium PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% 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 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No New York Heart Association class III or IV congestive heart failure No serious cardiac arrhythmia No history of cardiac toxicity from fluorouracil/leucovorin calcium No myocardial infarction within past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No uncontrolled predisposing colonic or small bowel disorder No prior chronic enteropathy, chronic diarrhea, or unresolved bowel obstruction/subobstruction No diabetes No active infection No known current peripheral neuropathy No concurrent active cancer except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No intolerance of appropriate antiemetics No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No prior irinotecan or oxaliplatin No other prior chemotherapy agents except fluorouracil with or without leucovorin calcium as first-line therapy for metastatic disease or in the adjuvant setting Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to non-target lesions allowed No prior radiotherapy to target lesions unless disease progression is documented within the radiation port At least 3 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgical procedure and recovered Prior surgery for primary tumor or metastasis allowed Other: At least 30 days since prior investigational drug No concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel G. Haller, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Institute of Huntsville
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Oncology Center at Providence Park
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Citrus Valley Medical Center
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kenmar Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Medical Oncology Care Associates
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
P.M.K. Medical Group, Inc.
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Cancer and Blood Institute of the Desert
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Kaiser Permanente-Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Kaiser Permanente Medical Center - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Colorado Permanente Medical Group, P.C.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Whittingham Cancer Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Comprehensive Cancer Care Specialists of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Center for Hematology-Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Southeast Florida Hematology-Oncology Group
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Shands Hospital and Clinics, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-100277
Country
United States
Facility Name
Hematology and Oncology Associates of Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida Health Science Center - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33804
Country
United States
Facility Name
Lake Heart and Cancer Medical Center
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Oncology-Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Hematology and Oncology Consultants, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Hematology/Oncology Associates
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Oncology & Hematology Associates of West Broward
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
University Community Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Hematology and Oncology Consultants
City
Titusville
State/Province
Florida
ZIP/Postal Code
32796
Country
United States
Facility Name
North Idaho Cancer Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Northwest Medical Specialists, P.C.
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Dreyer Medical Clinic
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60506
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cancer Care Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Healthcare Pavilion
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Veterans Affairs Medical Center - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Louisiana Oncology Associates
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Doctors Hospital of Jefferson
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Stanley Scott Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Greater Baltimore Medical Center and Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Medical Center of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Facility Name
Berkshire Hematology Oncology, P.C.
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Parker Hughes Cancer Center
City
Roseville
State/Province
Minnesota
ZIP/Postal Code
55113
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Veterans Affairs Medical Center - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Missouri Cancer Care, P.C.
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Western Montana Clinic
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7609
Country
United States
Facility Name
Somerset Medical Center
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Cooper Cancer Institute
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Veterans Affairs Medical Center - Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
Facility Name
Queens Medical Associates, PC
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Queens Hospital Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Interlakes Oncology/Hematology PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Raleigh Hematology/Oncology Associates - Wake Practice
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Piedmont Hematology-Oncology Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hematology Oncology Consultants Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Kaiser Permanente - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Pinnacle Health Hospitals
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17105-8700
Country
United States
Facility Name
Abington Hematology Oncology Associates, Incorporated
City
Meadowbrook
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Physicians East - Quadrangle
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Erlanger Health Systems
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Baptist Regional Cancer Center - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
Memphis Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Tennessee Oncology, P.L.L.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Lone Star Oncology
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Center for Oncology Research and Treatment, Medical City Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baptist Health System Cancer Program
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Hematology-Oncology Associates of Frederiksburg, Inc.
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Advanced Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
UW Cancer Center Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Irving Cancer Center
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82070
Country
United States
Facility Name
Porto Alegre Hospital
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Instituto de Oncologia de Soracaba
City
Sorocaba
State/Province
Sao Paulo
ZIP/Postal Code
18030-200
Country
Brazil
Facility Name
Hospital Joao Alves Fiho
City
Aracaiu-SE
ZIP/Postal Code
CEP: 49094-970
Country
Brazil
Facility Name
Hospital Socor
City
Belo Horizonte-MG
ZIP/Postal Code
CEP: 30180-060
Country
Brazil
Facility Name
Hospital Erastos Gaertner
City
Curitiba-PR
ZIP/Postal Code
CEP: 81520-060
Country
Brazil
Facility Name
Instituto Nacional de Cancer
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Oncologistas Associados
City
Rio de Janeiro
ZIP/Postal Code
CEP: 22260-020
Country
Brazil
Facility Name
Hospital do Cancer A C Comargo
City
Sao Paulo
ZIP/Postal Code
CEP: 01509-010
Country
Brazil
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Royal Victoria Hospital, Barrie
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre, Sudbury
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital - Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Charles Lemoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Cite de la Sante de Laval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
L'Hotel Dieu de Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Jewish General Hospital - Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hopital Du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL
City
Sainte Foy
State/Province
Quebec
ZIP/Postal Code
GIV 4G2
Country
Canada
Facility Name
L'Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Zoom International Incoporated
City
St. Jerome Quebec
ZIP/Postal Code
JYZ 5T3
Country
Canada
Facility Name
Centre of Clinical Oncology and Radiation Oncology
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czech Republic
Facility Name
Charles University Hospital
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czech Republic
Facility Name
Onkologicka Klinka A Onkologicka Lab
City
Prague
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Fakultni Nemocnice V Motole
City
Praha
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
City
Budapest
ZIP/Postal Code
H-1032
Country
Hungary
Facility Name
Szent Laszlo Korhaz
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Facility Name
Kozponti Honvedkorhaz I. Belgyogyaszat
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
Facility Name
Debreceni Egyetem Onkologiai Tanzek
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Petz Aladar County Hospital
City
Gydr
ZIP/Postal Code
h-9024
Country
Hungary
Facility Name
Maria S. Curie Memorial Institute
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Jagiellonian University
City
Krakow (Cracow)
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Institute of Oncology
City
Lodz
ZIP/Postal Code
93509
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii Oddzial Chemioterapii
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
St. Luke's Cancer Center
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 5XX
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's and St. Thomas' Hospitals NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18824706
Citation
Haller DG, Rothenberg ML, Wong AO, Koralewski PM, Miller WH Jr, Bodoky G, Habboubi N, Garay C, Olivatto LO. Oxaliplatin plus irinotecan compared with irinotecan alone as second-line treatment after single-agent fluoropyrimidine therapy for metastatic colorectal carcinoma. J Clin Oncol. 2008 Oct 1;26(28):4544-50. doi: 10.1200/JCO.2008.17.1249.
Results Reference
result

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Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

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