Gemcitabine With or Without WX-671 in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

NCT00499265 | Completed Phase 2

• 2 other identifiers: CDR0000553460WILEX-WX-60-004
• Study Type: interventional
• Target: 95
• Locations: 6 countries
• Sites: 39

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.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Gemcitabine

ACTIVE COMPARATOR

Drug: gemcitabine hydrochloride

Gemcitabine plus 200 mg WX-671

EXPERIMENTAL

Drug: Serine Proteinase Inhibitor WX-671

Gemcitabine plus 400 mg WX-671

EXPERIMENTAL

Drug: Serine Proteinase Inhibitor WX-671

Interventions

gemcitabine hydrochloride DRUG

1000 mg/m2 as 30 min i.v. infusion once weekly for 7/8 weeks and then every 3/4 weeks

Also known as: GEMZAR

Gemcitabine

Serine Proteinase Inhibitor WX-671 DRUG

oral, daily

Also known as: MESUPRON

Gemcitabine plus 200 mg WX-671

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced, unresectable, non-metastatic, histologically proven pancreatic adenocarcinoma (lymph nodes will not be considered metastases)

You may not qualify if:

• Any distant metastases
• PATIENT CHARACTERISTICS:
• ECOG performance status ≤ 1
• Life expectancy \> 12 weeks
• Normal 12-lead ECG or only clinically insignificant abnormalities in the judgment of the investigator
• Female patients of child-bearing potential will be required to use an effective method of birth control for the duration of the study to prevent pregnancy
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 2 times ULN or creatinine clearance \> 45 mL/min
• History of or current primary blood coagulation or bleeding disorders such as hemophilia
• Any unrelated illness, e.g., active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect the patient's study participation

Sponsors & Collaborators

• Heidelberg Pharma AG: lead

Study Sites (39)

Charite University Hospital - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Otto-Meyerhof-Zentrum Tagesklinik

Heidelberg, 69120, Germany

Location

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, D-39120, Germany

Location

Johannes Gutenberg University

Mainz, D-55101, Germany

Location

III Medizinische Klinik Mannheim

Mannheim, D-68305, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Hospital Muenchen Bogenhausen

Munich, D-81925, Germany

Location

Szent Laszlo Korhaz

Budapest, 1097, Hungary

Location

Debreceni Egyetem Onkologiai Tanzek

Debrecen, H-4012, Hungary

Location

Petz Aladar County Hospital

Gydr, h-9024, Hungary

Location

University of Pecs Faculty of Medicine

Pécs, H-7643, Hungary

Location

Szeged University

Szeged, H-6720, Hungary

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Presidio Ospedaliero di Livorno

Livorno, 57100, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli

Naples, 80131, Italy

Location

Istituto Tumori/Fondazione Pascale

Naples, 80131, Italy

Location

Ospedale San Filippo Neri

Rome, 00135, Italy

Location

Altai Oncology Center

Barnaul, 656049, Russia

Location

Moscow Oncology Hospital

Moscow, 109033, Russia

Location

Russian Academy of Medical Sciences Cancer Research Center

Moscow, 115478, Russia

Location

Central Clinical Hospital of the President of the Russian Federation

Moscow, 121356, Russia

Location

Rostov Research Institute of Oncology - Omsk

Omsk, 644013, Russia

Location

Pavlov State Medical University

Saint Petersburg, 197089, Russia

Location

Saint Petersburg State Medical University

Saint Petersburg, 197089, Russia

Location

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Universitario de Elche

Elche, 03203, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Centro Oncologico M.D. Anderson International Espana

Madrid, 28033, Spain

Location

Cherkassy Regional Oncology Center

Cherkassy, 18009, Ukraine

Location

Bukovinian State Medical University

Chernivtsy, 58002, Ukraine

Location

Dnipropetrovsk State Medical Academy

Dnipropetrovsk, 49600, Ukraine

Location

Donetsk Regional Antitumor Center

Donetsk, 83092, Ukraine

Location

Ivano-Frankovsk Regional Oncology Center

Ivano-Frankivsk, 76018, Ukraine

Location

Grigoriev Institute for Radiology Academy of Medical Science of Ukraine

Kharkiv, 61024, Ukraine

Location

Institute of Oncology

Kiev, 03022, Ukraine

Location

Ukrainian Medical Stomatological Academy

Poltava, 36024, Ukraine

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; upamostat

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Carola Mala, PhD

  Heidelberg Pharma AG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

RU (7); ES (5); UA (8); DE (9); IT (5); HU (5)