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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012389
• Other study ID #: CDR0000068524
• Secondary ID: SANOFI-EFC4585
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2001
• Last updated: December 18, 2013
• Start date: December 2000
• Est. completion date: October 2008

Study information

• Verified date: October 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

• oxaliplatin

Locations

Country	Name	City	State
Brazil	Hospital Joao Alves Fiho	Aracaiu-SE
Brazil	Hospital Socor	Belo Horizonte-MG
Brazil	Hospital Erastos Gaertner	Curitiba-PR
Brazil	Porto Alegre Hospital	Porto Alegre	Rio Grande do Sul
Brazil	Instituto Nacional de Cancer	Rio de Janeiro
Brazil	Oncologistas Associados	Rio de Janeiro
Brazil	Hospital do Cancer A C Comargo	Sao Paulo
Brazil	Instituto de Oncologia de Soracaba	Sorocaba	Sao Paulo
Canada	Royal Victoria Hospital, Barrie	Barrie	Ontario
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Cite de la Sante de Laval	Laval	Quebec
Canada	L'Hotel Dieu de Levis	Levis	Quebec
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Jewish General Hospital - Montreal	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Centre Hospitalier de L'Universitaire de Quebec, Pavillon CHUL	Sainte Foy	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Zoom International Incoporated	St. Jerome Quebec
Canada	L'Hopital Laval	Ste-Foy	Quebec
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Czech Republic	Centre of Clinical Oncology and Radiation Oncology	Ceske Budejovice
Czech Republic	Charles University Hospital	Hradec Kralove
Czech Republic	Onkologicka Klinka A Onkologicka Lab	Prague
Czech Republic	Fakultni Nemocnice V Motole	Praha
Hungary	Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia	Budapest
Hungary	Kozponti Honvedkorhaz I. Belgyogyaszat	Budapest
Hungary	National Institute of Oncology	Budapest
Hungary	Semmelweis University	Budapest
Hungary	Szent Laszlo Korhaz	Budapest
Hungary	Debreceni Egyetem Onkologiai Tanzek	Debrecen
Hungary	Petz Aladar County Hospital	Gydr
Poland	Maria S. Curie Memorial Institute	Gliwice
Poland	Jagiellonian University	Krakow (Cracow)
Poland	Institute of Oncology	Lodz
Poland	Wielkopolskie Centrum Onkologii Oddzial Chemioterapii	Poznan
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	St. Luke's Cancer Center	Guildford	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Guy's and St. Thomas' Hospitals NHS Trust	London	England
United Kingdom	St. Bartholomew's Hospital	London	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Weston Park Hospital	Sheffield	England
United Kingdom	Royal Marsden Hospital	Sutton	England
United States	Veterans Affairs Medical Center - Albany	Albany	New York
United States	Northwest Medical Specialists, P.C.	Arlington Heights	Illinois
United States	Dreyer Medical Clinic	Aurora	Illinois
United States	Lone Star Oncology	Austin	Texas
United States	Greater Baltimore Medical Center and Cancer Center	Baltimore	Maryland
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Bend Memorial Clinic	Bend	Oregon
United States	Center for Hematology-Oncology	Boca Raton	Florida
United States	Comprehensive Cancer Care Specialists of Boca Raton	Boca Raton	Florida
United States	Medical Center of Boston	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Erlanger Health Systems	Chattanooga	Tennessee
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	North Idaho Cancer Center	Coeur d'Alene	Idaho
United States	Hematology Oncology Consultants Inc	Columbus	Ohio
United States	Citrus Valley Medical Center	Covina	California
United States	Center for Oncology Research and Treatment, Medical City Hospital	Dallas	Texas
United States	Colorado Permanente Medical Group, P.C.	Denver	Colorado
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Southeast Florida Hematology-Oncology Group	Fort Lauderdale	Florida
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Hematology-Oncology Associates of Frederiksburg, Inc.	Fredericksburg	Virginia
United States	Queens Medical Associates, PC	Fresh Meadows	New York
United States	Shands Hospital and Clinics, University of Florida	Gainesville	Florida
United States	Great Falls Clinic	Great Falls	Montana
United States	California Cancer Care, Inc.	Greenbrae	California
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Physicians East - Quadrangle	Greenville	South Carolina
United States	Pinnacle Health Hospitals	Harrisburg	Pennsylvania
United States	Comprehensive Cancer Institute of Huntsville	Huntsville	Alabama
United States	Jackson Oncology Associates, PLLC	Jackson	Mississippi
United States	Hematology and Oncology Associates of Jacksonville	Jacksonville	Florida
United States	University of Florida Health Science Center - Jacksonville	Jacksonville	Florida
United States	Queens Hospital Center	Jamaica	New York
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	Baptist Regional Cancer Center - Knoxville	Knoxville	Tennessee
United States	Louisiana Oncology Associates	Lafayette	Louisiana
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Irving Cancer Center	Laramie	Wyoming
United States	Lake Heart and Cancer Medical Center	Leesburg	Florida
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Kenmar Research Institute	Los Angeles	California
United States	Tower Hematology Oncology Medical Group	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Kentuckiana Cancer Institute	Louisville	Kentucky
United States	Norton Healthcare Pavilion	Louisville	Kentucky
United States	Veterans Affairs Medical Center - Louisville	Louisville	Kentucky
United States	Abington Hematology Oncology Associates, Incorporated	Meadowbrook	Pennsylvania
United States	Memphis Cancer Center	Memphis	Tennessee
United States	West Clinic	Memphis	Tennessee
United States	Doctors Hospital of Jefferson	Metairie	Louisiana
United States	Oncology-Hematology Group of South Florida	Miami	Florida
United States	Advanced Health Care	Milwaukee	Wisconsin
United States	Western Montana Clinic	Missoula	Montana
United States	Oncology Center at Providence Park	Mobile	Alabama
United States	Tennessee Oncology, P.L.L.C.	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Cancer Care Center	New Albany	Indiana
United States	Stanley Scott Cancer Center	New Orleans	Louisiana
United States	Whittingham Cancer Center	Norwalk	Connecticut
United States	Medical Oncology Care Associates	Orange	California
United States	Hematology and Oncology Consultants, P.A.	Orlando	Florida
United States	P.M.K. Medical Group, Inc.	Oxnard	California
United States	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Berkshire Hematology Oncology, P.C.	Pittsfield	Massachusetts
United States	Hematology/Oncology Associates	Port Saint Lucie	Florida
United States	Kaiser Permanente - Portland	Portland	Oregon
United States	Lifespan: The Miriam Hospital	Providence	Rhode Island
United States	Raleigh Hematology/Oncology Associates - Wake Practice	Raleigh	North Carolina
United States	Cancer and Blood Institute of the Desert	Rancho Mirage	California
United States	Interlakes Oncology/Hematology PC	Rochester	New York
United States	Parker Hughes Cancer Center	Roseville	Minnesota
United States	Siteman Cancer Center	Saint Louis	Missouri
United States	St. John's Mercy Medical Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Baptist Health System Cancer Program	San Antonio	Texas
United States	Kaiser Permanente-Southern California Permanente Medical Group	San Diego	California
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Somerset Medical Center	Somerville	New Jersey
United States	Missouri Cancer Care, P.C.	St. Charles	Missouri
United States	Oncology & Hematology Associates of West Broward	Tamarac	Florida
United States	University Community Hospital	Tampa	Florida
United States	Hematology and Oncology Consultants	Titusville	Florida
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	New York Medical College	Valhalla	New York
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Cooper Cancer Institute	Voorhees	New Jersey
United States	George Washington University Medical Center	Washington	District of Columbia
United States	UW Cancer Center Wausau Hospital	Wausau	Wisconsin
United States	Piedmont Hematology-Oncology Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Czech Republic,  Hungary,  Poland,  United Kingdom, 

References & Publications (1)

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 colo — View Citation