Ignite Creation Date:
2024-05-05 @ 10:16 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01077986
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2010-02-25
Brief Title:
Everolimus Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
A Phase I II Non-randomized Feasibility Safety and Efficacy Study of the Combination of Everolimus Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
This phase III non randomized single center study will be performed as a two step design Part I is dose finding whereby dose escalations will be performed for everolimus and capecitabine Part II is the efficacy study At the MTD doses in part II biomarker studies will be performed in blood and tumor tissue Study design phase I part The first week patients will be treated with everolimus alone Capecitabine will be administered for 14 days in a 3 weekly cycle starting on day 8 Cetuximab will be administered weekly starting at day 8 The dose is fixed for cetuximab during study treatment whereas the doses of everolimus and capecitabine will differ per dose level First dose level Everolimus 5 mg daily continuously Capecitabine 600 mgm2 bid for 2 weeks every 3 weeks Cetuximab 400mgm2 120 min infusion first dose thereafter 250 mgm2 60 min infusion weekly Second dose level Everolimus 10 mg daily continuously Capecitabine 600 mgm2 bid for 2 weeks every 3 weeks Cetuximab 400mgm2 120 min infusion first dose thereafter 250 mgm2 60 min infusion weekly Third dose level Everolimus 10 mg daily continuously Capecitabine 800 mgm2 bid for 2 weeks every 3 weeks Cetuximab 400mgm2 120 min infusion first dose thereafter 250 mgm2 60 min infusion weekly Study design phase II part At the MTD 14-25 patients with pancreatic cancer will be included In the phase II part everolimus will be administered during one week before start of cetuximab At day 8 the first dose of cetuximab will be administered Capecitabine will be started one week thereafter This enables us to perform pharmacodynamic studies to assess biomarker changes during the different phases of treatment Everolimus will be administered continuously in a dose of 5 or 10 mg orally once daily dependent on MTD from part 1 Capecitabine will be administered orally in a dose of 400 - 800 mgm2 twice daily for 14 days followed by one week rest dependent on MTD from part 1 Patients will receive cetuximab infusions via an infusion pump with an initial dose of 400 mgm² over 120 min and subsequent weekly infusions of 250 mgm² over 60 min starting day 8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None