Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019773
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Oxaliplatin Plus Capecitabine in Treating Patients With Colorectal Appendix or Small Bowel Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients
Status:
COMPLETED
Status Verified Date:
2003-04
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have colorectal appendix or small bowel cancer
PURPOSE Phase I trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have colorectal appendix or small bowel cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of capecitabine when administered with oxaliplatin in patients with colorectal appendiceal or small bowel cancer
Determine the clinical toxic effects associated with this regimen in these patients
Characterize the molecular profile of tumor tissue obtained prior to study entry for determinants of sensitivity to this regimen in this patient population
Characterize the molecular profile of a surrogate normal tissue bone marrow aspirate obtained prior to treatment and assess any potential drug-associated induction of DNA damage and inhibition of thymidylate synthase with a repeat bone marrow aspirate during therapy
Assess any clinical activity of this regimen in this patient population
OUTLINE This is a dose-escalation study of capecitabine
Patients receive oxaliplatin IV over 2 hours on day 1 followed by oral capecitabine twice daily on days 1-5 and 8-12 Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 6 months
PROJECTED ACCRUAL A total of 106 patients will be accrued for this study within 36 months
Determine the maximum tolerated dose MTD of capecitabine when administered with oxaliplatin in patients with colorectal appendiceal or small bowel cancer
Determine the clinical toxic effects associated with this regimen in these patients
Characterize the molecular profile of tumor tissue obtained prior to study entry for determinants of sensitivity to this regimen in this patient population
Characterize the molecular profile of a surrogate normal tissue bone marrow aspirate obtained prior to treatment and assess any potential drug-associated induction of DNA damage and inhibition of thymidylate synthase with a repeat bone marrow aspirate during therapy
Assess any clinical activity of this regimen in this patient population
OUTLINE This is a dose-escalation study of capecitabine
Patients receive oxaliplatin IV over 2 hours on day 1 followed by oral capecitabine twice daily on days 1-5 and 8-12 Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 6 months
PROJECTED ACCRUAL A total of 106 patients will be accrued for this study within 36 months
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-99-C-0117 | None | None | None |
| MB-NAVY-99-01 | None | None | None |
| NCI-T99-0011 | None | None | None |