Status:
COMPLETED
Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer
Lead Sponsor:
Carmen Schade-Brittinger
Conditions:
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.
Detailed Description
Available study data indicated a possible benefit from adjuvant chemotherapy for patients with resected pancreatic cancer. The optimal therapy regimen has yet to be determined. Based on the experienc...
Eligibility Criteria
Inclusion
- Provided signed written informed consent.
- Men and woman age \> 18 years
- Histologically confirmed R0 OR R1 resected ductal adenocarcinoma of the pancreas
- Life expectancy \>12 weeks
- Patients with performance status of ECOG ≤ 2
- Patients without metastasis
Exclusion
- Women of child bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and follow-up to 4 weeks after the study.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for \> 5 years will be allowed to enter the trial).
- Inadequate hematologic function defined by an absolute neutrophils count (ANC) \< 1,500/mm³, a platelet count \< 100,000/mm³ and a hemoglobin \< 9 g/dL.
- Inadequate hepatic function defined by the upper limit of normal (ULN), AST and ALT levels \> 5 times the ULN.
- Serum bilirubin \> 1.5 times the ULN.
- Inadequate renal function defined by a serum creatinine \> 1.5 times the ULN.
- Prior cetuximab or other therapy that targets the EGF pathway.
- Prior antibody therapy.
- Any known allergic reaction against cetuximab.
- Any concurrent chronic systemic immune therapy, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agents.
- HIV infection.
- Having participated in another clinical trial in the preceding 30 days.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00395252
Start Date
October 1 2006
End Date
January 1 2012
Last Update
October 2 2015
Active Locations (8)
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1
Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)
Fulda, Germany, 36043
2
Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
3
Klinik für Innere Medizin II, Klinikum der Universität Jena
Jena, Germany, 07740
4
Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel
Kassel, Germany, 34125