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FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01219920
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Gruppo Oncologico del Nord-Ovest

Brief Summary:
The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of response rate to conventional chemotherapy with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: FOLFIRI Drug: FOLFOXIRI Phase 3

Detailed Description:

Survival of patients with metastatic colorectal cancer is correlated with the proportion of patients who receive all the three active drugs in the course of the disease, but not with the proportion of patients who receive any second-line therapy. In a sequential strategy, not all patients who progress after first-line chemotherapy are able to receive second-line treatment. Moreover, there is a correlation between the response rate to chemotherapy and the postchemotherapy radical resection rate of metastases.

Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a first-line regimen containing the three active agents.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) as First-line Treatment for Metastatic Colorectal Cancer
Study Start Date : November 2001
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FOLFIRI
Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks
Drug: FOLFIRI
Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks
Other Names:
  • Campto
  • l-lederfolin
  • 5-FU

Experimental: FOLFOXIRI
Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
Drug: FOLFOXIRI
Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
Other Names:
  • Campto
  • Eloxatin
  • l-leucovorin
  • 5FU




Primary Outcome Measures :
  1. Response rate (RR) [ Time Frame: Responses are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of treatment (6 months) ]
    Responses are evaluated every 8 weeks according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Progressions are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of follow up (36 months) ]
    PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause, whichever occurred first, or to last contact.

  2. Overall survival (OS) [ Time Frame: For survival analysis participants are followed until death ]
    OS is defined as the length of time from random assignment to death or to last contact.

  3. Postchemotherapy radical (R0) surgical resection rate of metastases [ Time Frame: Postchemotherapy radical (R0) surgical resection rate of metastases were evaluated every 8 weeks during treatment and during follow up (36 months) ]
    Percentage of patients who undergo radical (R0) resection of metastases after achieving objective response to chemotherapy.

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Number of Participants with Adverse Events as a Measure of Safety and Tolerability were evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months) ]
    During the full lenght of first-line treatment, number of enrolled patients reporting adverse events is recorded. Adverse events are evaluated according to National Cancer Institute Common Toxicity Criteria version 2.0.

  5. Quality of life (QoL) [ Time Frame: Quality of life was evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months) ]

    Quality of life is assessed at the beginning of each treatment cycle using the Quality of Life Questionnaire of the European Organisation for Research and Treatment of Cancer (version 2.0).

    The QLQ-C30 questionnaire was analyzed with the global health status/quality-of-life scale as the primary end point and the other 10 scales as secondary end points.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adenocarcinoma of the colon or rectum
  • unresectable metastatic disease
  • age 18 to 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years measurable disease according to WHOcriteria
  • leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3
  • serum creatinine of 1.3 mg/dL or less
  • serum bilirubin less than 1.5 mg/dL and AST, ALT, and alkaline phosphatase 2.5 x normal values or less (</= 5 if liver metastases)
  • previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment

Exclusion Criteria:

  • previous palliative chemotherapy for metastatic disease
  • previous chemotherapy including irinotecan or oxaliplatin
  • symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
  • active infections
  • inflammatory bowel disease
  • total colectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219920


Locations
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Italy
Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al) Oncologia Medica
Alessandria, Italy, 15100
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona - Ancona (An) Oncologia Medica
Ancona, Italy, 60100
Ausl Della Valle D' Aosta (Ao) - Aosta (Ao) Oncologia Medica
Aosta, Italy, 11100
P.O. Zona Aretina - Ospedale S. Donato Di Arezzo - Arezzo (Ar) Oncologia Medica
Arezzo, Italy, 52100
Azienda Ospedale `G.Rummo` - Benevento (Bn) Oncologia Medica
Benevento, Italy, 82100
Ospedale Degli Infermi Di Biella - Biella (Bi) Oncologia Medica
Biella, Italy, 13900
Ospedale S. Orsola F.B.F. - Brescia - Brescia (Bs) Oncologia Medica
Brescia, Italy, 25122
Stabilimento "Perrino" - Brindisi - Brindisi (Br) Oncologia Medica
Brindisi, Italy, 72100
Azienda Ospedaliera S. Elia - Caltanissetta (Cl) Oncologia Medica
Caltanissetta, Italy, 93100
Ospedale Versilia - Camaiore (Lu) Oncologia Medica
Camaiore, Italy, 55043
Ospedale Cecina - Cecina (Li) Oncologia Medica
Cecina, Italy, 57023
Istituti Ospitalieri - Cremona - Cremona (Cr) Oncologia Medica
Cremona, Italy, 26100
Azienda Ospedaliera S. Croce E Carle Di Cuneo - Cuneo (Cn) Oncologia Medica
Cuneo, Italy, 12100
Ausl 11 Di Empoli (Fi) - Empoli (Fi) Oncologia Medica
Empoli, Italy, 50053
Asur - Zona Territoriale 6 Di Fabriano (An) - Fabriano (An) Oncologia Medica
Fabriano, Italy, 60044
Ospedale Santa Croce Fano - Fano (Pu) Oncologia Medica
Fano, Italy, 61032
Ausl 10 Di Firenze - Firenze (Fi) Oncologia Medica
Firenze, Italy, 50122
A.O. Universitaria Careggi Di Firenze Oncologia Medica
Firenze, Italy, 50134
E.O. Ospedali Galliera - Genova (Ge) Oncologia Medica
Genova, Italy, 16128
Irccs Istituto Nazionale Per La Ricerca Sul Cancro (Ist) - Genova (Ge) Oncologia Medica
Genova, Italy, 16132
Ospedale Sant`Andrea La Spezia - La Spezia (Sp) Oncologia Medica
La Spezia, Italy, 19100
Ausl Le Di Lecce - Lecce (Le) Oncologia Chirurgica
Lecce, Italy, 73100
Ospedale Per Acuti "Mater Salutis" Legn. - Legnago (Vr) Oncologia Medica
Legnano, Italy, 37045
U.O. Oncologia Medica, Ospedale Civile
Livorno, Italy, 57123
Presidio Ospedaliero Piana Di Lucca - Lucca (Lu) Oncologia Medica
Lucca, Italy, 55100
Irccs Fondazione Centro S. Raffaele Del Monte Tabor - Milano (Mi) Oncologia Medica
Milano, Italy, 20132
Ospedale Ca` Granda-Niguarda - Milano - Milano (Mi) Oncologia Medica
Milano, Italy, 20162
Ospedale Civile Di Mirano - Mirano (Ve) Oncologia Medica
Mirano, Italy, 30035
A.O. Universitaria Federico Ii Di Napoli Oncologia Medica
Napoli, Italy, 80131
A.O. Universitaria Maggiore Della Carita' Di Novara Oncologia Medica
Novara, Italy, 28100
A.O. Universitaria Di Parma Oncologia Medica
Parma, Italy, 43100
Asl 1 Di Citta' Di Castello (Pg) - Citta' Di Castello (Pg) Oncologia Medica
Perugia, Italy, 06012
A.O. Di Perugia - Ospedale S. Maria Della Misericordia (Ex Silvestrini) - Perugia (Pg) Oncologia Medica
Perugia, Italy, 06156
Azienda Ospedaliera San Salvatore - Pesaro (Pu) Oncologia Medica
Pesaro, Italy, 61100
Ospedale Piombino - Piombino (Li) Oncologia Medica
Piombino, Italy, 57025
Ausl 5 Di Pisa - Pisa (Pi) Oncologia Medica
Pisa, Italy, 56100
A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
Pisa, Italy, 56126
A.O. Universitaria Pisana Oncologia Medica
Pisa, Italy, 56126
Ausl 3 Di Pistoia - Pistoia (Pt) Oncologia Medica
Pistoia, Italy, 51100
Ospedali Riuniti Di Pistoia - Pistoia (Pt) Oncologia Medica
Pistoia, Italy, 51100
Ospedale Di S. Maria Nuova - Reggio Nell`Emilia
Reggio Emilia, Italy, 42100
Policlinico Universitario Campus Bio-Medico Di Roma Oncologia Medica
Roma, Italy, 00128
Policlinico Umberto I Di Roma Oncologia Medica
Roma, Italy, 00161
Policlinico Universitario Gemelli Di Roma Oncologia Medica
Roma, Italy, 00168
A.O. Universitaria Senese Oncologia Medica
Siena, Italy, 53100
Ausl 7 Di Siena - Siena (Si) Oncologia Medica
Siena, Italy, 53100
Ospedale Civile - Sondrio - Sondrio (So) Oncologia Medica
Sondrio, Italy, 23100
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Oncologia Medica
Torino, Italy, 10134
Sponsors and Collaborators
Gruppo Oncologico del Nord-Ovest
Investigators
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Principal Investigator: Alfredo Falcone, MD University of Pisa

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gruppo Oncologico del Nord-Ovest
ClinicalTrials.gov Identifier: NCT01219920     History of Changes
Other Study ID Numbers: ASL601LIOM03
2007-002886-11 ( EudraCT Number )
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Gruppo Oncologico del Nord-Ovest:
Metastatic colorectal cancer
Phase III
FOLFOXIRI
FOLFIRI
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Fluorouracil
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs