Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005791
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Irinotecan Cisplatin and Fluorouracil in Patients With Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2009-12
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 combination chemotherapy in treating patients who have locally advanced or metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of weekly irinotecan in combination with weekly fluorouracil and cisplatin in patients with locally advanced or metastatic solid tumors II Determine the dose limiting toxicity for this combination regimen in this patient population III Establish a recommended phase II dose for this combination regimen in these patients IV Evaluate the safety and tolerability of this regimen in these patients V Observe any responses to this combination chemotherapy in these patients VI Measure in pretreatment biopsies levels of expression of thymidylate synthase topoisomerase I ERCC-1 thymidine phosphorylase and dihydropyrimidine dehydrogenase as correlates to response or resistance to this combination chemotherapy in these patients
OUTLINE This is a dose escalation study of irinotecan and fluorouracil Patients receive cisplatin IV over 30 minutes followed by fluorouracil IV over several minutes followed by irinotecan IV over 30 minutes on days 1 8 15 and 22 Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression for a minimum of 3 courses Cohorts of 3-6 patients receive escalating doses of irinotecan and fluorouracil until the maximum tolerated dose MTD of each is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities Patients are followed at 30 days and then until death
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 1-2 years
OUTLINE This is a dose escalation study of irinotecan and fluorouracil Patients receive cisplatin IV over 30 minutes followed by fluorouracil IV over several minutes followed by irinotecan IV over 30 minutes on days 1 8 15 and 22 Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression for a minimum of 3 courses Cohorts of 3-6 patients receive escalating doses of irinotecan and fluorouracil until the maximum tolerated dose MTD of each is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities Patients are followed at 30 days and then until death
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| NCI-G00-1743 | None | None | None |
| MSKCC-99065 | None | None | None |