Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260364
Status:
COMPLETED
Last Update Posted:
2016-10-14
First Post:
2005-11-29
Brief Title:
Combining Erlotinib Plus Bevacizumab and Gemcitabine Plus Capecitabine to Treat Advanced Pancreatic Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
A Phase I-II Dose Finding and Early Efficacy Study of Combination Therapy With Erlotinib Tarceva Gemcitabine Bevacizumab Avastin and Capecitabine in Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2010-01
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:
TARGET
Brief Summary:
Pancreatic cancer is an aggressive largely chemo-resistant disease with a poor prognosis EGFR and VEGF are both overexpressed in pancreatic cancers and thought to contribute to tumour development and progression The combination of gemcitabine and capecitabine has recently been shown to be effective in advanced pancreatic cancer The combination of gemcitabine plus erlotinib has also been shown to be effective in advanced pancreatic cancer The aim of this study is to assess whether combining a chemotherapy doublet gemcitabine plus capecitabine and a biologic doublet erlotinib plus bevacizumab is a safe and effective way to treat advanced pancreatic cancer by targeting multiple tumour stimulating mechanisms simultaneously
Detailed Description:
To establish the safety and efficacy of a combination of four drugs capecitabine gemcitabine erlotinib and bevacizumab in the treatment of patients with locally advanced or metastatic pancreatic cancer The study will be divided into two parts
Part A Phase I Is to establish the optimal dose of capecitabine for combination with gemcitabine bevacizumab and erlotinib This part of the study is necessary in order to characterise any increased side effects that may occur as a result of this combination of drugs The dose of capecitabine will be increased in cohorts containing 3 to 6 patientsaccording to standard dose escalation study design whilst side effects are closely monitored The doses of the other three drugs will remain fixed during this period
Gemcitabine 1000 mgm2 Days 1 8 15
Bevacizumab 5 mgkg every two weeks iv
Erlotinib 100 mgday orally
Maximum tolerated dose is the dose at which 2 out of a cohort of three to six patients experience dose-limiting toxicity within the first cycle 28 days of treatment The recommended dose for further evaluation will be one dose level below this
Part B Phase II Once a recommended dose of capecitabine has been chosen this will be used for the remainder of the trial to further characterise the efficacy and safety of the drug combination in this group of patients
Part A Phase I Is to establish the optimal dose of capecitabine for combination with gemcitabine bevacizumab and erlotinib This part of the study is necessary in order to characterise any increased side effects that may occur as a result of this combination of drugs The dose of capecitabine will be increased in cohorts containing 3 to 6 patientsaccording to standard dose escalation study design whilst side effects are closely monitored The doses of the other three drugs will remain fixed during this period
Gemcitabine 1000 mgm2 Days 1 8 15
Bevacizumab 5 mgkg every two weeks iv
Erlotinib 100 mgday orally
Maximum tolerated dose is the dose at which 2 out of a cohort of three to six patients experience dose-limiting toxicity within the first cycle 28 days of treatment The recommended dose for further evaluation will be one dose level below this
Part B Phase II Once a recommended dose of capecitabine has been chosen this will be used for the remainder of the trial to further characterise the efficacy and safety of the drug combination in this group of patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT No 2005-002715-24 | None | None | None |