Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004187
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2000-01-21
Brief Title:
Capecitabine and Oxaliplatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
A Phase I-II Study of Capecitabine and Oxaliplatin in Chemotherapy-Naive and Thymidylate Synthase Inhibitor Pretreated Advanced or Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2019-06
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 III trial to study the effectiveness of combining capecitabine and oxaliplatin in treating patients who have advanced or metastatic colorectal cancer that cannot be surgically removed
PURPOSE Phase III trial to study the effectiveness of combining capecitabine and oxaliplatin in treating patients who have advanced or metastatic colorectal cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of capecitabine when combined with oxaliplatin in patients with chemotherapy naive or thymidylate synthase inhibitor pretreated unresectable advanced or metastatic colorectal cancer II Determine the safety profile toxicity and efficacy of this regimen in these patients III Determine the complete and partial remission rates time to treatment failure and overall survival of patients treated with this regimen
OUTLINE This is a dose escalation multicenter study of capecitabine Patients are stratified by pretreatment status any pretreatment vs chemotherapy naive vs thymidylate synthase inhibitor pretreatment Phase I Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine every 12 hours on days 1-14 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which 2 or more of 6 patients experience dose limiting toxicity Phase II Patients receive capecitabine at the feasible dose The feasible dose is defined as the dose immediately preceding the MTD from phase I Patients are followed every 3 months for 1 year and then every 6 months thereafter until death
PROJECTED ACCRUAL Approximately 18 patients will be accrued for phase I of the study and a total of 27-68 patients 14-25 thymidylate synthase inhibitor pretreated patients and 13-43 chemotherapy naive patients will be accrued for phase II of the study
OUTLINE This is a dose escalation multicenter study of capecitabine Patients are stratified by pretreatment status any pretreatment vs chemotherapy naive vs thymidylate synthase inhibitor pretreatment Phase I Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine every 12 hours on days 1-14 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which 2 or more of 6 patients experience dose limiting toxicity Phase II Patients receive capecitabine at the feasible dose The feasible dose is defined as the dose immediately preceding the MTD from phase I Patients are followed every 3 months for 1 year and then every 6 months thereafter until death
PROJECTED ACCRUAL Approximately 18 patients will be accrued for phase I of the study and a total of 27-68 patients 14-25 thymidylate synthase inhibitor pretreated patients and 13-43 chemotherapy naive patients will be accrued for phase II of the study
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 |
|---|---|---|---|
| EU-99026 | None | None | None |
| SWS-SAKK-41-99 | None | None | None |