Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-01 @ 4:10 PM
Study NCT ID:
NCT00885066
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2009-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
Centre Antoine Lacassagne
Organization:
Study Overview
Official Title:
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
Status:
COMPLETED
Status Verified Date:
2015-02
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:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.
Secondary
* Analyze the limiting toxicities according to CTC.
* Analyze the toxicity according to CTC.
* Determine the recommended dose.
* Determine the pharmacokinetic dosages of the three drugs.
* Analyze interactions between the drugs.
OUTLINE: This is a multicenter study.
Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.
Primary
* Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.
Secondary
* Analyze the limiting toxicities according to CTC.
* Analyze the toxicity according to CTC.
* Determine the recommended dose.
* Determine the pharmacokinetic dosages of the three drugs.
* Analyze interactions between the drugs.
OUTLINE: This is a multicenter study.
Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: