Everolimus, Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer

NCT01077986 | Completed Phase 1 DMC

• 1 other identifier: AMCmedonc08/345
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Pancreatic Cancer

Keywords

mTOR inhibition; EGFR inhibition; pancreatic cancer; pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• phase I part: assessment of the dose limiting toxicity

  During treatment: assessments on day 1 every cycle (3 weeks). After treatment: every 3 months during the first 2 years, and every 6 months thereafter

• phase II part: response rate

  Assessments after every 3 cycles (9 weeks).

Secondary Outcomes (4)

• Time to treatment failure

  Every 3 months during the first 2 years, and every 6 months thereafter.

• Overall survival

  Every 3 months during the first 2 years, and every 6 months thereafter.

• Toxicity profile

  During treatment: assessments on day 1 every cycle (3 weeks). After treatment: every 3 months during the first 2 years, and every 6 months thereafter.

• Pharmacodynamics: biomarkers in blood and tumor tissue

  Day 1, 8 and 22 during treatment

Interventions

Capecitabine DRUG

Capecitabine will be administered for 14 days in a 3 weekly cycle, starting on day 8.

Also known as: Xeloda

Cetuximab DRUG

Cetuximab will be administered weekly, starting at day 8.

Also known as: Erbitux

Everolimus DRUG

Everolimus will be administered daily, starting on day 1.

Also known as: certican

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Cetuximab; Everolimus

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Hanneke Wilmink, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 2, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2011
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

NL (1)