- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00235898
Clinical Trial in Patients With Metastatic Colorectal Cancer
22. august 2008 opdateret af: Mast Therapeutics, Inc.
A Multi-Center, Open Label, Parallel Group, Randomised, Phase IIB Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-FU Versus Leucovorin and 5-FU in Subjects With Metastatic Colorectal Carcinoma
The objective of this trial is to compare efficacy and safety of CoFactor and 5-fluorouracil (5-FU) versus leucovorin and 5-FU in treatment of metastatic colorectal cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
300
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Glasgow, Det Forenede Kongerige, G11 6NT
- Beatson Oncology Centre
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Essex
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Harlow, Essex, Det Forenede Kongerige, CM20 1QX
- Haematology/Lung/GI Cancer Services
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London
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Middlesex, London, Det Forenede Kongerige, N18 1QX
- Oncology Research, North Middlesex University Hospital
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Bangalore, Indien, 560017
- Manipal Hospital
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Jaipur, Indien, 302004
- SMS Medical College Hospital
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Ludhiana, Indien, 141001
- Department of Medical Oncology, Dayanad Medical College and Hospital
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Mumbai, Indien, 400 026
- Department of Medical Oncology, Jaslok Hospital and Research Centre
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indien, 500 004
- Global Hospital
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Hyderabad, Andhra Pradesh, Indien, 560 082
- Department of Medical Oncology, Nizam's Institute of Medical Sciences
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Attavar
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Mangalore, Attavar, Indien, 575001
- Kasturba Medical College
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Erandawane
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Pune, Erandawane, Indien, 411004
- Department of Medical Oncology, Deenanath Mangeshkar Hospital and Research Centre
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Karnataka
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Bangalore, Karnataka, Indien, 560029
- Department of Medical Oncology, Kidwai Memorial Institute of Oncology
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Tamil Nadu
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Vellore, Tamil Nadu, Indien, 632004
- Department of Oncology, Christian Medical College
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Gdansk, Polen, 80-211
- Department and Clinic for Oncology and Radiotherapy
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Gdynia Redlowo, Polen
- Department for Oncology and Radiotherapy, Szpital Morski im. PCK
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Lodz, Polen, 93-509
- Oncological Chemotherapy Clinic, Regionalny Osrodek Onkologiczny
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Lublin, Polen, 20-090
- Oncological Chemotherapy Department Centrum Onkologii Ziemi
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Torun, Polen, 87-100
- Clinical Oncology Department, Wojewodski Szpital Zespolony
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Warszawa
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Roentgena, Warszawa, Polen
- Colorectal Cancer Clinic, Centrum Cancer Clinic Onkologii-Instytut im M. Skladowskiej-Curie
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Bucharest, Rumænien, 022328
- Gastroenterology and Hepatology Department, Fundeni Clinical Institute
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Bucharest, Rumænien
- Professor of Dr. Alexandru Trestioreanu, Institute of Oncology II
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Cluj-Napoca, Rumænien, 400015
- Department of Medical Oncology and Radiotherapy II
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Sibiu, Rumænien, 550245
- Medical Oncology Department, County Hospital Sibiu
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Belgrade, Serbien, 11 000
- Clinical Center of Serbia
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Belgrade, Serbien, 11 000
- Institute of Oncology and Radiology Serbia
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Belgrade, Serbien
- CHC Bezanijska
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Kragujevac, Serbien, 34000
- CHC Kragujevac
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Nis, Serbien, 21104
- Clinic Centre Nis
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Sremska Kamenica, Serbien, 21104
- Clinic for Internal Medicine, Institute for Oncology Sremska
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Zrenjanin, Serbien, 23000
- General Hospital Djordje Joanovic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma.
- Be male or non-pregnant, non-lactating female subjects ≥ 18 years of age.
- If female, and of childbearing potential, agree to use adequate contraception (as deemed by the investigator) throughout their participation in this study and for 30 days after discontinuation of study medication.
- If, female of childbearing potential, have a negative pregnancy test prior to the start of the study.
- Have a life expectancy of at least 6 months.
- Have radiologically or clinically measurable disease for response assessment. Presence of ascites or pleural effusion(s) are not acceptable as single sites of response assessment, but may be present if dimensional or other discrete measurable disease is present for evaluation.
- Have an ECOG Performance Level of 0-2 (or Karnofsky of 100-70). A lower ECOG or Karnofsky is acceptable only if clearly due to non-oncologic conditions (e.g., prior paraplegia from polio).
- Have had no prior chemotherapy for established, metastatic disease. (Subjects may have received adjuvant chemotherapy with fluoropyrimidine therapy).
- Have at least 6 months elapsed since prior adjuvant 5-FU or CPT-11 therapy, or Mitomycin C or nitrosourea therapy.
- Have had at least an 8 week interval since any prior radiation therapy or 4 weeks since any major surgery.
- Have recovered from any toxicities resulting from prior therapies (except for alopecia).
- Adequate renal, bone marrow, liver function defined as serum creatinine less than 1.5 times the upper limit of normal, serum bilirubin less than 2 times the upper limit of normal, ANC greater than 1.5 x 109/L, Platelet count greater than 90 x 109/L, SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal.
Exclusion Criteria:
- Failure by the subject or the subject's legal representative to sign the Informed Consent.
- An inability to obtain Informed Consent because of psychiatric or complex medical problems.
- Have concurrent infection including diagnoses of FUO or evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
- Have unstable oncologic emergency syndromes: superior vena cava (SVC) syndrome, rising bilirubin needing stent placement, spinal cord compression, progressive brain metastases, active bleeding, hypercalcemia, etc.
- Have unstable medical conditions such as acute coronary syndrome, cardio-vascular accident within the previous 12 months (such as transient ischemic attacks, accelerated hypertension), etc.
- Have cerebellar neurologic syndromes such as Parkinson's disease, multiple sclerosis, and amyotonia.
- Have a known intolerance to fluoropyrimidine (5-FU, Capecitabine, Floxuridine, UFT) therapy (dihydropyrimidine dehydrogenase deficiency).
- Patients with vomiting, diarrhea, or nausea of grade greater than 1.
- Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
CoFactor, 5-FU
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Andre navne:
Andre navne:
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Aktiv komparator: 2
Leucovorin, 5-FU
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Andre navne:
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: James Cassidy, MD, Beatson Oncology Centre
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2005
Primær færdiggørelse (Faktiske)
1. marts 2008
Datoer for studieregistrering
Først indsendt
6. oktober 2005
Først indsendt, der opfyldte QC-kriterier
10. oktober 2005
Først opslået (Skøn)
12. oktober 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. august 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. august 2008
Sidst verificeret
1. august 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Rektale neoplasmer
- Colon neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Beskyttelsesagenter
- Mikronæringsstoffer
- Vitaminer
- Modgift
- Vitamin B kompleks
- Fluorouracil
- Leucovorin
Andre undersøgelses-id-numre
- 03-CoFactor
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Endetarmskræft
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Institut BergoniéAfsluttetMedium og Lower Rectal CancerFrankrig
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Fundación de investigación HMSyntax for Science, S.LAfsluttetLocally Advanced Rectal Cancer (LARC)Spanien
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King Faisal Specialist Hospital & Research CenterAfsluttetColon Rectal Cancer Duke Stage StagevalSaudi Arabien
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Austrian Breast & Colorectal Cancer Study GroupAfsluttetRectal Cancer Dukes B, Dukes CØstrig
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University Health Network, TorontoAfsluttet
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Sir Run Run Shaw HospitalAktiv, ikke rekrutterendeMSS Locally Advanced Rectal AdenocarcinomaKina
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Sunnybrook Health Sciences CentreUniversity of Toronto; Sunnybrook Research InstituteAfsluttetRectal Neoplasma Carcinoma in Situ AdenocarcinomaCanada
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Philips HealthcarePhilips Electronics Nederland B.V. acting through Philips CTO organizationAfsluttetMalignt lymfom i lymfeknuder i lyskeregionen | Malignt lymfom af lymfeknuder i aksillært | Malignt lymfom af lymfeknuder i livmoderhalsen | Karcinom i parotidkirtlen | Colon Rectal Cancer Tubulovillous Adenocarcinoma | Tumor af blødt væv i hoved, ansigt og halsHolland
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Stanford UniversityAfsluttetGastrointestinale neoplasmer | Kræft i bugspytkirtlen | Spiserørskræft | Anal kræft | Hepatobiliær neoplasma | Gastroøsofageal kræft | Galdeblærekarcinom | Leverkarcinom | Galdeblærekræft | Gastrointestinal stromal tumor (GIST) | Karcinom i tyktarmen | Gastrisk (mave) kræft | Galdevejscarcinom | Colon Rectal Cancer AdenocarcinomForenede Stater
Kliniske forsøg med Leucovorin
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Haruhiko FukudaMinistry of Health, Labour and Welfare, JapanAfsluttetKolorektale neoplasmerJapan
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Royal Marsden NHS Foundation TrustMerck Serono International SAAfsluttet
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National Taiwan University HospitalMackay Memorial Hospital; Taipei Veterans General Hospital, Taiwan; National... og andre samarbejdspartnereAfsluttet
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University of California, San FranciscoAfsluttet
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Southwest Autism Research & Resource CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAktiv, ikke rekrutterendeAutismespektrumforstyrrelseForenede Stater
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Marks, John, M.D.AfsluttetRektale neoplasmerForenede Stater
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University of California, San FranciscoNational Cancer Institute (NCI)AfsluttetHoved- og halskræftForenede Stater
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Fudan UniversityUkendt
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National Health Research Institutes, TaiwanMackay Memorial Hospital; China Medical University Hospital; Chang Gung Memorial... og andre samarbejdspartnereUkendtAdenocarcinom | TyktarmssygdommeTaiwan
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Southwest Autism Research & Resource CenterUnited States Department of Defense; State University of New York - Downstate...RekrutteringAutismespektrumforstyrrelse | SprogforstyrrelserForenede Stater