Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 7:46 PM
Study NCT ID:
NCT00433550
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2007-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2017-07
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:
This phase II trial studies how well giving irinotecan hydrochloride together with oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic or unresectable locally advanced small bowel cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVE:
To assess the confirmed tumor response of the combination of oxaliplatin, irinotecan (irinotecan hydrochloride), and capecitabine in patients with advanced adenocarcinoma of the small bowel when dosed according to UGT1A1 genotype.
SECONDARY OBJECTIVES:
1. To assess the toxicity of this regimen in these groups of patients.
2. To gain preliminary data on whether microsatellite instability influences outcome within this arm.
3. To gain preliminary data on whether evidence of celiac disease may affect toxicity and outcome.
4. To gain preliminary data on whether site of tumor origin (duodenal, jejunal, or ileal) affects response or survival.
OUTLINE: Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype.
GROUP 1 (6/6 UGT1A1 genotype): Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 2-15.
GROUP 2 (6/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses.
GROUP 3 (7/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.
In all groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed every 6 weeks for 2 years and then periodically thereafter.
To assess the confirmed tumor response of the combination of oxaliplatin, irinotecan (irinotecan hydrochloride), and capecitabine in patients with advanced adenocarcinoma of the small bowel when dosed according to UGT1A1 genotype.
SECONDARY OBJECTIVES:
1. To assess the toxicity of this regimen in these groups of patients.
2. To gain preliminary data on whether microsatellite instability influences outcome within this arm.
3. To gain preliminary data on whether evidence of celiac disease may affect toxicity and outcome.
4. To gain preliminary data on whether site of tumor origin (duodenal, jejunal, or ileal) affects response or survival.
OUTLINE: Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype.
GROUP 1 (6/6 UGT1A1 genotype): Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 2-15.
GROUP 2 (6/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses.
GROUP 3 (7/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.
In all groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed every 6 weeks for 2 years and then periodically thereafter.
Study Oversight
Has Oversight DMC:
True
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?: