Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotnib Followed of Capecitabine - Full Text View

Sponsors and Collaborators:	Ludwig-Maximilians - University of Munich Hoffmann-La Roche
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00440167

Purpose

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

Condition	Intervention	Phase
Advanced Pancreatic Cancer	Drug: gemcitabine Drug: capecitabine Drug: Erlotinib	Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Capecitabine Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Randomised Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotnib Followed of Capecitabine in Patients With Advanced Pancreatic Cacner

Further study details as provided by Ludwig-Maximilians - University of Munich:

Study Start Date:

June 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Age between 18 and 75 years
Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1)
No option for resection with curative intent
At least one measurable or not measurable lesion (according to RECIST)
No previous chemotherapy or other systemic tumor therapy
No previous radiation
Performance-Status 0-2 according to WHO/ECOG
Life expectance of at least 3 months
Adequate kidney-, liver- and bone marrow function, defined as
Absolute neutrophile count * 1,5 x 109/l
Hemoglobin * 8 g/dl
Thrombocytes * 100 x 109/l
Bilirubin * 2 x upper norm (with liver mets < 5-fold)
Serum Creatinine * 1,25 x upper norm
Creatinine clearance > 30 ml/min (Cockroft/Gault)
Transaminases * 2,5 x upper norm (with liver mets < 5-fold)
Possibility of regular long-term follow-up
Negative pregnancy test in women at childbearing age
All patients must have signed an informed consent before study entry.

Exclusion Criteria:

Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri
Clinically instabile CNS-metastases
Known hypersensitivity against study medication
Severe impairment of renal function (creatinine clearance < 30 ml/min)
Severe impairment of liver function (bilirubin > 2,0 x above upper norm, transaminases > 2,5 x upper norm, or with known liver metastasis >5 x upper norm)
Clinically relevant disease of the cardiovascular system or other vital organs
Known polyneuropathy
Known DPD-deficiency (screening not required)
Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin
Pregnancy, lactation or lack of reliable contraception in women at childbearing age
Mental disease, drug- or alcohol abuse
Participation in another clinical trial within the last 4 weeks
All other diseases which may prevent adequate participation in the trial
Indication of lack of compliance with study regulations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440167

Contacts

Contact: Volker Heinemann, MD	+49 89 7095 0	volker.heinemann@med.uni-muenchen.de
Contact: Stefan Boeck, MD	+49 89 7095 0	stefan.boeck@med.uni-muenchen.de

Locations

Germany
Onkologische Praxis	Recruiting
Landshut, Germany, 84028
Contact: Vehling-Kaiser, MD
Principal Investigator: U. Vehling-Kaiser, MD
Onkologische Praxis	Recruiting
Kronach, Germany, 96317
Contact: Stauch, MD
Principal Investigator: Stauch, MD
Städtisches Klinikum Karlsruhe	Recruiting
Karlsruhe, Germany, 76133
Contact: Binnenhei, MD
Principal Investigator: Binnenhei, MD
Otto-Meyerhof-Zentrum Tagesklinik	Recruiting
Heidelberg, Germany, 69120
Contact: Maerten, MD
Principal Investigator: Maerten, MD
Onkologische Praxis	Recruiting
Soden, Germany, 65812
Contact: Seipelt, MD
Principal Investigator: Seipelt, MD
Staeisches Klinikum Magdeburg	Recruiting
Magdeburg, Germany, 39104
Contact: Kettner, MD
Principal Investigator: Kettner
GPR Klinikum Rüsselsheim GmbH	Recruiting
Ruesselsheim, Germany, 65428
Contact: Heringer, MD
Principal Investigator: Heringer, MD

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Hoffmann-La Roche

Investigators

Principal Investigator:

Volker Heinemann, MD

University of Munich - Klinikum Grosshadern

More Information

Study ID Numbers:	RC-57 crossover
Study First Received:	February 22, 2007
Last Updated:	February 22, 2007
ClinicalTrials.gov Identifier:	NCT00440167
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:

capecitabine
gemcitabine
Erlotinib
pancreatic cancer

Study placed in the following topic categories:

Erlotinib
Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases

Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Protein Kinase Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009