Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350753
Status:
COMPLETED
Last Update Posted:
2009-07-15
First Post:
2006-07-10
Brief Title:
Avastin and Tarceva for Upper Gastrointestinal Cancers
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas Refractory or Intolerable to Standard Systemic Therapy
Status:
COMPLETED
Status Verified Date:
2009-07
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:
Erlotinib and bevacizumab have shown activity individually as single drugs or in combination with chemotherapy in upper gastro-intestinal cancers including esophageal and gastro-esophageal adenocarcinomas gastric cancer and pancreatic cancer Biomarkers indicating an important role of EGF and VEGF have been found in these tumors and in cholangiocarcinomas as well There is promise that combined treatment with erlotinib and bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers justifying an experimental phase II-study of patients with these diagnoses refractory or intolerant to standard systemic therapy
Detailed Description:
Primary Objective
To determine the median time to progression TTP and response rate RR of the combination of erlotinib and bevacizumab in patients with advanced upper gastro-intestinal carcinomas refractory or intolerant to standard systemic therapy
Secondary Objective
To determine safety tolerability and toxicity
To determine median and overall survival OS
To correlate efficacy of treatment with the expression of tumor markers obtained in serum EFGR bFGF p-VEGF-A and sVEGF-R2 in paraffin embedded tumor tissue micro vessel density MVD and expression of VEGFR and EGFR after immunostaining and in fresh frozen tumor biopsies micro array-based analyses of patterns of gene expression
Treatment
Bevacizumab AvastinÒ will be given intravenously at 10 mgkg every other week
Erlotinib is given as an orally daily dose and most be taken at least one hour before or two hours after ingestion of food
To determine the median time to progression TTP and response rate RR of the combination of erlotinib and bevacizumab in patients with advanced upper gastro-intestinal carcinomas refractory or intolerant to standard systemic therapy
Secondary Objective
To determine safety tolerability and toxicity
To determine median and overall survival OS
To correlate efficacy of treatment with the expression of tumor markers obtained in serum EFGR bFGF p-VEGF-A and sVEGF-R2 in paraffin embedded tumor tissue micro vessel density MVD and expression of VEGFR and EGFR after immunostaining and in fresh frozen tumor biopsies micro array-based analyses of patterns of gene expression
Treatment
Bevacizumab AvastinÒ will be given intravenously at 10 mgkg every other week
Erlotinib is given as an orally daily dose and most be taken at least one hour before or two hours after ingestion of food
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 |
|---|---|---|---|
| 2006-001308-35 | None | None | None |