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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 to 75	Other	RC-57 crossover NCT00440167

Trial Description

Summary

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

Volker Heinemann, MD

Principal Investigator

Volker Heinemann, MD		Ph: +49 89 7095 0
		Email: volker.heinemann@med.uni-muenchen.de

Stefan Boeck, MD		Ph: +49 89 7095 0
		Email: stefan.boeck@med.uni-muenchen.de

Germany
	Heidelberg
	Universitaets-Kinderklinik Heidelberg
		Maerten, MD
		Maerten, MD	Principal Investigator
	Karlsruhe
	Staedtisches Klinikum Karlsruhe gGmbH
		Binnenhei, MD
		Binnenhei, MD	Principal Investigator
	Kronach
	Internistische Onkologische Praxis - Kronach
		Stauch, MD
		Stauch, MD	Principal Investigator
	Landshut
	Internistische Praxis - Landshut
		Vehling-Kaiser, MD
		U. Vehling-Kaiser, MD	Principal Investigator
	Magdeburg
	Staedtisches Klinikum Magdeburg - Altstadt
		Kettner, MD
		Erika Kettner	Principal Investigator
	Ruesselsheim
	Internistische Schwerpunktpraxis
		Heringer, MD
		Heringer, MD	Principal Investigator
	Soden
	Onkologische Praxis
		Seipelt, MD
		Seipelt, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00440167
Information obtained from ClinicalTrials.gov on March 18, 2009