Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433550
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2007-02-08
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:
Alliance for Clinical Trials in Oncology
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 66 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 67 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 77 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 66 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 67 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 77 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:
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 |
|---|---|---|---|
| CDR0000528263 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2009-00650 | REGISTRY | None | None |