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

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
Pancreatic Cancer	Drug: Gemcitabine Drug: Capecitabine Drug: Erlotinib	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

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

U.S. FDA Resources

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

Primary Outcome Measures:

TTF2 [ Time Frame: approximate 6 months after first line treatment ] [ Designated as safety issue: No ]
Time to treatment failure, after 2nd line (crossover) therapy

Secondary Outcome Measures:

TTF1 [ Time Frame: approximate 6 months after randomization ] [ Designated as safety issue: No ]
Time to treatment failure
Remission Rate [ Time Frame: approximate 6 months after randomization ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 42 months after randomization ] [ Designated as safety issue: No ]
Clinical Benefit Response [ Time Frame: approximate 6 months after randomization ] [ Designated as safety issue: No ]
Tumor marker CA19-9 characteristics [ Time Frame: approximate 6 months after randomization ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: approximate 6 months after randomization ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: approximate 6 months after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm A	Drug: Capecitabine Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing") Drug: Erlotinib Erlotinib 150 mg/d oral, daily without break
Active Comparator: Arm B	Drug: Gemcitabine Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28 Drug: Erlotinib Erlotinib 150 mg/d oral, daily without break

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 expectancy of at least 3 months
Adequate kidney-, liver- and bone marrow function, defined as
Absolute neutrophil 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 unstable 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

Sponsors and Collaborators

PD Dr. med. Volker Heinemann

Roche Pharma AG

Investigators

Principal Investigator:

Volker Heinemann, MD

University of Munich - Klinikum Grosshadern

More Information

No publications provided by Ludwig-Maximilians - University of Munich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heinemann V, Vehling-Kaiser U, Waldschmidt D, Kettner E, Märten A, Winkelmann C, Klein S, Kojouharoff G, Gauler TC, von Weikersthal LF, Clemens MR, Geissler M, Greten TF, Hegewisch-Becker S, Rubanov O, Baake G, Höhler T, Ko YD, Jung A, Neugebauer S, Boeck S. Gemcitabine plus erlotinib followed by capecitabine versus capecitabine plus erlotinib followed by gemcitabine in advanced pancreatic cancer: final results of a randomised phase 3 trial of the 'Arbeitsgemeinschaft Internistische Onkologie' (AIO-PK0104). Gut. 2013 May;62(5):751-9. doi: 10.1136/gutjnl-2012-302759. Epub 2012 Jul 7.

Responsible Party:	PD Dr. med. Volker Heinemann, Sponsor Delegatated Person, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00440167 History of Changes
Other Study ID Numbers:	RC-57 crossover
Study First Received:	February 22, 2007
Last Updated:	July 5, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:

capecitabine
gemcitabine
Erlotinib
pancreatic cancer
advanced

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Fluorouracil
Erlotinib
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013