Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine
NCT ID: NCT00440167
Last Updated: 2012-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2006-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm A
Capecitabine
Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")
Erlotinib
Erlotinib 150 mg/d oral, daily without break
Arm B
Gemcitabine
Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
Erlotinib
Erlotinib 150 mg/d oral, daily without break
Interventions
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Gemcitabine
Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
Capecitabine
Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")
Erlotinib
Erlotinib 150 mg/d oral, daily without break
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
PD Dr. med. Volker Heinemann
OTHER
Responsible Party
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PD Dr. med. Volker Heinemann
Sponsor Delegatated Person
Principal Investigators
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Volker Heinemann, MD
Role: PRINCIPAL_INVESTIGATOR
University of Munich - Klinikum Grosshadern
Countries
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References
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Weiss L, Heinemann V, Fischer LE, Gieseler F, Hoehler T, Mayerle J, Quietzsch D, Reinacher-Schick A, Schenk M, Seipelt G, Siveke JT, Stahl M, Vehling-Kaiser U, Waldschmidt DT, Dorman K, Zhang D, Westphalen CB, von Bergwelt-Baildon M, Boeck S, Haas M. Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection? Clin Transl Oncol. 2024 May;26(5):1268-1272. doi: 10.1007/s12094-023-03323-1. Epub 2023 Oct 4.
Guenther M, Surendran SA, Haas M, Heinemann V, von Bergwelt-Baildon M, Engel J, Werner J, Boeck S, Ormanns S. TPX2 expression as a negative predictor of gemcitabine efficacy in pancreatic cancer. Br J Cancer. 2023 Jul;129(1):175-182. doi: 10.1038/s41416-023-02295-x. Epub 2023 May 4.
Guenther M, Haas M, Heinemann V, Kruger S, Westphalen CB, von Bergwelt-Baildon M, Mayerle J, Werner J, Kirchner T, Boeck S, Ormanns S. Bacterial lipopolysaccharide as negative predictor of gemcitabine efficacy in advanced pancreatic cancer - translational results from the AIO-PK0104 Phase 3 study. Br J Cancer. 2020 Oct;123(9):1370-1376. doi: 10.1038/s41416-020-01029-7. Epub 2020 Aug 24.
Ormanns S, Siveke JT, Heinemann V, Haas M, Sipos B, Schlitter AM, Esposito I, Jung A, Laubender RP, Kruger S, Vehling-Kaiser U, Winkelmann C, Fischer von Weikersthal L, Clemens MR, Gauler TC, Marten A, Geissler M, Greten TF, Kirchner T, Boeck S. pERK, pAKT and p53 as tissue biomarkers in erlotinib-treated patients with advanced pancreatic cancer: a translational subgroup analysis from AIO-PK0104. BMC Cancer. 2014 Aug 28;14:624. doi: 10.1186/1471-2407-14-624.
Heinemann V, Vehling-Kaiser U, Waldschmidt D, Kettner E, Marten 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, Hohler 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.
Other Identifiers
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RC-57 crossover
Identifier Type: -
Identifier Source: org_study_id