Everolimus, Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study the investigators want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by EGFR and mTOR inhibition in patients with metastatic pancreatic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Treatments: Capecitabine; Cetuximab; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Signed informed content obtained prior to treatment

• Cytological or histological confirmed adenocarcinoma of the pancreas

• Metastatic pancreatic cancer

• Measurable lesion according to RECIST criteria

• ECOG/ WHO performance 0-2

• Age > 18 years

• Life expectancy > 3 months

• Adequate renal function (creatinine < 150 µmol/L)

• Adequate liver function (bilirubin < 1.5 times upper limit of normal, ALAT or ASAT < 5.0 times upper limit of normal in case of liver metastases and < 2.5 the upper limit of normal in absence of liver metastases

• Adequate bone marrow function (WBC > 3.0 x 10 9/L, platelets > 100 x 10 9/L)

• Mentally, physically, and geographically able to undergo treatment and follow up

Exclusion Criteria:

• Clinical or radiological evidence of CNS metastases

• Pregnancy (positive serum pregnancy test) and lactation

• Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator

• Patients who have any severe and/or uncontrolled medical conditions

• Previous treatment with an mTOR inhibitor