Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carmen Schade-Brittinger
• Treatments: Cetuximab; Gemcitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.