Gemcitabine With or Without WX-671 in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00499265
- Lead Sponsor
- Heidelberg Pharma AG
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with WX-671 may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well gemcitabine works when given together with WX-671 or when given alone in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
- Detailed Description
OBJECTIVES:
Primary
* Assess the antitumor activity of two different doses of anti-uPA serine protease inhibitor WX-671 when given in combination with gemcitabine hydrochloride in patients with locally advanced unresectable pancreatic cancer.
* Compare the efficacy, in terms of response rate, progression-free survival, time to first metastasis, overall survival, and tumor and uPA system-related markers, of these regimens in these patients.
* Compare the safety, in terms of vital signs, ECG, biochemistry, hematology (including coagulation), and adverse events, of these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive of oral anti-uPA serine protease inhibitor WX-671 once daily in weeks 1-8 (weeks 1-4 of each subsequent course) and gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral anti-uPA serine protease inhibitor WX-671 (at a lower dose than in arm I) once daily in weeks 1-8 (weeks 1-4 of each subsequent course) and gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 (weeks 1-3 of each subsequent course) of course 1. All subsequent courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine gemcitabine hydrochloride - Gemcitabine plus 200 mg WX-671 Serine Proteinase Inhibitor WX-671 - Gemcitabine plus 400 mg WX-671 Serine Proteinase Inhibitor WX-671 -
- Primary Outcome Measures
Name Time Method Efficacy, in terms of response rate, progression-free survival, time to first metastasis, overall survival, and tumor and uPA system-related markers 3 years Safety, in terms of vital signs, ECG, biochemistry, hematology (including coagulation), and adverse events 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
University of Pecs Faculty of Medicine
🇭🇺Pecs, Hungary
Debreceni Egyetem Onkologiai Tanzek
🇭🇺Debrecen, Hungary
Petz Aladar County Hospital
🇭🇺Gydr, Hungary
Szeged University
🇭🇺Szeged, Hungary
Hospital Muenchen Bogenhausen
🇩🇪Munich, Germany
Charite University Hospital - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Szent Laszlo Korhaz
🇭🇺Budapest, Hungary
Johannes Gutenberg University
🇩🇪Mainz, Germany
III Medizinische Klinik Mannheim
🇩🇪Mannheim, Germany
Rostov Research Institute of Oncology - Omsk
🇷🇺Omsk, Russian Federation
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
🇮🇹Naples, Italy
Istituto Tumori/Fondazione Pascale
🇮🇹Naples, Italy
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Presidio Ospedaliero di Livorno
🇮🇹Livorno, Italy
Russian Academy of Medical Sciences Cancer Research Center
🇷🇺Moscow, Russian Federation
Ospedale San Filippo Neri
🇮🇹Rome, Italy
Cherkassy Regional Oncology Center
🇺🇦Cherkassy, Ukraine
Pavlov State Medical University
🇷🇺St. Petersburg, Russian Federation
Institute of Oncology
🇺🇦Kiev, Ukraine
Altai Oncology Center
🇷🇺Barnaul, Russian Federation
Moscow Oncology Hospital
🇷🇺Moscow, Russian Federation
Hospital de la Santa Cruz i Sant Pau
🇪🇸Barcelona, Spain
Bukovinian State Medical University
🇺🇦Chernivtsy, Ukraine
Ivano-Frankovsk Regional Oncology Center
🇺🇦Ivano-Frankovsk, Ukraine
Ukrainian Medical Stomatological Academy
🇺🇦Poltava, Ukraine
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Dnipropetrovsk State Medical Academy
🇺🇦Dnipropetrovsk, Ukraine
Donetsk Regional Antitumor Center
🇺🇦Donetsk, Ukraine
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Saint Petersburg State Medical University
🇷🇺Saint Petersburg, Russian Federation
Grigoriev Institute for Radiology Academy of Medical Science of Ukraine
🇺🇦Kharkiv, Ukraine
Hospital Universitario de Elche
🇪🇸Elche, Spain
Otto-Meyerhof-Zentrum Tagesklinik
🇩🇪Heidelberg, Germany
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Central Clinical Hospital of the President of the Russian Federation
🇷🇺Moscow, Russian Federation
Centro Oncologico M.D. Anderson International Espana
🇪🇸Madrid, Spain