A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
12 mars 2014 uppdaterad av: Clovis Oncology, Inc.
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Pancreatic cancer is a very serious form of cancer. The majority of patients present with unresectable disease, and the condition is often not diagnosed until the cancer is relatively advanced. The standard first-line treatment for patients with unresectable pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to derive benefit from this treatment. No clinical or molecular marker has been established to predict benefit from gemcitabine therapy, so patients are treated empirically until evidence of disease progression or worsening performance status.
The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict survival in gemcitabine-treated patients has been studied, and data suggest that patients with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine treatment than patients with high levels of tumor cell hENT1 expression. These data support the hypothesis to be tested in this study that patients with pancreatic tumors expressing low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.
Studietyp
Interventionell
Inskrivning (Faktisk)
367
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Córdoba, Argentina, X5004FHP
- Clínica Universitaria Reina Fabiola
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Santa Fe, Argentina, S3000FFU
- ISIS Centro especializado
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Bahia Blanca
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Buenos Aires, Bahia Blanca, Argentina, B8000FJI
- Policlínica Privada Instituto de Medicina Nuclear
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Buenos Aires
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Cuidad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Instituto Especializado Alexander Fleming
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Loma Hermosa, Buenos Aires, Argentina, B1657BHD
- Hospital de Gastroenterología
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New South Wales
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New Lambton Heights, New South Wales, Australien, 2305
- Newcastle Private Hospital
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Port Macquarie, New South Wales, Australien, 2444
- Port Macquarie Base Hospital
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Wollongong, New South Wales, Australien, 2500
- Southern Medical Day Oncology Care Centre
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South Australia
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Bedford Park, South Australia, Australien, 5042
- Flinders Medical Centre
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Victoria
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Fitzroy, Victoria, Australien, 3065
- Saint Vincent's Hospital
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Wodonga, Victoria, Australien, 3690
- Border Medical Oncology, Murray Valley Private Hospital
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint Luc
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Haine-Saint-Paul, Belgien, 7100
- Centre Hospitalier de Jolimont-Lobbes
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Antwerpen
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Edegem, Antwerpen, Belgien, 2650
- Universitair Ziekenhuis Antwerpen
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Rio de Janeiro, Brasilien, 20231
- Instituto Nacional do Câncer
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Distrito Federal
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Brasilia, Distrito Federal, Brasilien, 70840
- Hospital Universitario
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 60430-230
- Santa Casa de Misericordia de Belo Horizonte
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasilien, 90610-000
- Hospital Sao Lucas - PUCRS
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90020
- Irmandade da Santa
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Santa Catarina
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Florianópolis, Santa Catarina, Brasilien, 88034-000
- CEPON-Centro de Pesquisas Oncológicas
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Sao Paulo
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Barretos, Sao Paulo, Brasilien, 14784-400
- Hospital do Cancer de Barretos
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Jau, Sao Paulo, Brasilien, 17210
- Fundacao Hospital
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Santo Andre, Sao Paulo, Brasilien, 09060-650
- Faculdade de Medicina do ABC
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Bayonne Cedex, Frankrike, 64109
- Centre Hospitalier de la Côte Basque
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Bordeaux, Frankrike, 33000
- Hôpital Saint André, Service d'Oncologie Médicale
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Limoges Cedex, Frankrike, 87039
- Clinique Francois Chenieux
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Montpellier, Frankrike, 34298
- Centre Regional de Lutte contre le Cancer Val d'Aurelle
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Montpellier Cedex 5, Frankrike, 34295
- Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
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Saint Herblain cedex, Frankrike, 44805
- Centre Rene Gauducheau
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Villejuif Cedex, Frankrike, 94805
- Institut Gustave-Roussy - Centre de Lutte Contre le Cancer
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Arizona
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Glendale, Arizona, Förenta staterna, 85306
- Arizona Center for Hematology Oncology
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California
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Corona, California, Förenta staterna, 92879
- Wilshire Oncology Medical Group, Inc.
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Los Angeles, California, Förenta staterna, 90033
- White Memorial Medical Center
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Los Angeles, California, Förenta staterna, 90036
- Cancer Care Institute
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Newport Beach, California, Förenta staterna, 92660
- Newport Cancer Care Medical
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Oakland, California, Förenta staterna, 94609
- Hematology Oncology Associates
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San Diego, California, Förenta staterna, 92123
- Sharp Clinical Oncology Research
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Colorado
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Denver, Colorado, Förenta staterna, 80218
- Rocky Mountain Cancer Centers
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06102
- Hartford Hospital Clinical Research
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Trumbull, Connecticut, Förenta staterna, 06611
- Oncology Associates of Bridgeport
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Maryland
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Annapolis, Maryland, Förenta staterna, 21401
- Annapolis Oncology Center
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55407
- Virginia Piper Cancer Institute
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New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08901
- The Cancer Institute of New Jersey
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87109
- New Mexico Cancer Care Alliance
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New York
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Lake Success, New York, Förenta staterna, 11042
- Arena Oncology Associates, PC
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Oregon
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Bend, Oregon, Förenta staterna, 97701
- Bend Memorial Clinic
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29605
- Cancer Center Of The Carolinas
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Texas
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Corpus Christi, Texas, Förenta staterna, 78412
- Cancer Specialists of South Texas, P.A.
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Harlingen, Texas, Förenta staterna, 78550
- Valley Cancer Associates
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San Antonio, Texas, Förenta staterna, 78229
- South Texas Oncology and Hematology, PA
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
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Milano, Italien, 20132
- Fondazione San Raffaele del Monte Tabor
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Padova, Italien, 35128
- Instituto Oncologico Veneto, Oncologia Medica 1
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Torrette di Ancona, Italien, 60020
- Ospedali Riuniti di Ancona
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Verona, Italien, 37134
- Centro Ricerche Cliniche Di Verona
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italien, 40138
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
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Noord-Holland
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Amsterdam, Noord-Holland, Nederländerna, 1081 HV
- Vrije Universiteit Medisch Centrum
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Kristiansand, Norge, 4604
- Sørlandet Sykehus HF
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Oslo, Norge, 0407
- Oslo universitetssykehus, Ullevål
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Ekaterinburg, Ryska Federationen, 620036
- Sverdlovsk Regional Oncology Center
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Irkutsk, Ryska Federationen, 664035
- Regional Oncology Center
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Krasnodar, Ryska Federationen, 350040
- Clinical Oncology Center #1
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Kursk, Ryska Federationen, 305035
- Kursk Regional Oncology Center
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Moscow, Ryska Federationen, 115478
- Blokhin Cancer Research Center
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Novosibirsk, Ryska Federationen, 630047
- Novosibirsk, City Clinical Hospital #1
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St. Petersburg, Ryska Federationen, 194291
- Leningrad Regional Clinical Hospital
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St. Petersburg, Ryska Federationen, 195067
- Mechnikov St. Petersburg State Medical Academy
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St. Petersburg, Ryska Federationen, 197785
- St. Petersburg City Oncology Center
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Tambov, Ryska Federationen, 392013
- Tambov Regional Oncology Center
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Tula, Ryska Federationen, 300053
- Tula Regional Oncology Center
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Yaroslavl, Ryska Federationen, 150040
- Regional Clinical Oncology Hospital
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Republic of Udmurtia
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Izhevsk, Republic of Udmurtia, Ryska Federationen, 426067
- Republic Clinical Oncology Center
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England
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London, England, Storbritannien, W12 0HS
- Hammersmith Hospital
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Manchester, England, Storbritannien, M20 4BX
- Christie Hospital
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Scotland
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Glasgow, Scotland, Storbritannien, G12 0YN
- Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)
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Jonkoping, Sverige, 551 85
- Länssjukhuset Ryhov
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Linköping, Sverige, 581 85
- Linköping University Hospital
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Växjö, Sverige, 351 85
- Växjö Centrallasarettet
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Berlin, Tyskland, 13353
- Charité Universitätsmedizin Berlin
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Dresden, Tyskland, 01307
- Universitatsklinikum Carl Gustav Carus
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Magdeburg, Tyskland, 39120
- Klinik der Otto-Von-Guericke-Universität Magdeburg
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Ulm, Tyskland, 89081
- Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I
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Bayern
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München, Bayern, Tyskland, 81377
- Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München
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Mecklenburg-Vorpommern
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Greifswald, Mecklenburg-Vorpommern, Tyskland, 17475
- Klinikum der Ernst-Moritz-Arndt-Universität
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Nordrhein-Westfalen
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Bochum, Nordrhein-Westfalen, Tyskland, 44892
- Knappschaftskrankenhaus Bochum-Langendreer
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Thueringen
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Jena, Thueringen, Tyskland, 07740
- Universitatsklinikum Jena
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Dnipropetrovsk, Ukraina, 49102
- Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology
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Donetsk, Ukraina, 83092
- Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6
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Kharkiv, Ukraina, 61070
- "Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department
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Kiev, Ukraina, 03022
- National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum
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Lviv, Ukraina, 79031
- State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department
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Mykolayiv, Ukraina, 54044
- Mykolayiv Regional Oncology Center, Surgery Department #1
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Uzhorod, Ukraina, 88014
- Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department
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Zaporizhya, Ukraina, 69032
- Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
- Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H&E stain) to ensure sufficient material is available for later hENT1 analysis.
- Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.
- Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.
- CT scan ≤30 days prior to randomization
- Performance Status (ECOG) 0 or 1.
- Estimated life expectancy ≥ 12 weeks.
- Age ≥ 18 years.
- Adequate hematological and biological function.
- Written consent on an Institutional Review Board/Institutional Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.
Exclusion Criteria:
- Prior palliative chemotherapy for pancreatic cancer.
- Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
- Symptomatic brain metastases.
- Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.
- Concomitant treatment with prohibited medications.
- History of allergy to gemcitabine or eggs.
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
- Any disorder that would hamper protocol compliance.
- Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
- Females who are pregnant or breastfeeding.
- Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last study treatment). Adequate forms of contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal ligation.
- Any other reason the investigator considers the patient should not participate in the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: gemcitabin
|
1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
|
|
Experimentell: CO-1.01
|
1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Tidsram: Monthly follow up after treatment discontinuation until death, up to 1.5 years.
|
Monthly follow up after treatment discontinuation until death, up to 1.5 years.
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Overall Survival in All Patients and Patients With hENT1 Expression
Tidsram: Monthly follow up after treatment discontinuation until death, up to 1.5 years
|
Monthly follow up after treatment discontinuation until death, up to 1.5 years
|
|
ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years
Tidsram: Every 8 weeks
|
Every 8 weeks
|
|
Cancer Antigen (CA)19-9 Response Rates
Tidsram: Every 4 weeks, up to 1.5 years
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Every 4 weeks, up to 1.5 years
|
|
Drug Tolerability and Toxicity
Tidsram: Every week, up to 1.5 years
|
Every week, up to 1.5 years
|
|
Change From Baseline in Pain Severity
Tidsram: Every 4 weeks, up to 1.5 years
|
Every 4 weeks, up to 1.5 years
|
|
Change From Baseline in Health Status
Tidsram: Every 4 weeks, up to 1.5 years
|
Every 4 weeks, up to 1.5 years
|
|
Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling
Tidsram: 30 days after first dose
|
30 days after first dose
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2010
Primärt slutförande (Faktisk)
1 november 2012
Avslutad studie (Faktisk)
1 juni 2013
Studieregistreringsdatum
Först inskickad
12 maj 2010
Först inskickad som uppfyllde QC-kriterierna
14 maj 2010
Första postat (Uppskatta)
17 maj 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 april 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 mars 2014
Senast verifierad
1 mars 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Carcinom
- Neoplasmer, körtel och epitel
- Adenocarcinom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Gemcitabin
Andra studie-ID-nummer
- CO-101-001
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .