Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003742
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Trial of Paclitaxel Cisplatin and Irinotecan in Patients With Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2013-06
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 I trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of paclitaxel when combined with cisplatin and irinotecan in patients with locally advanced or metastatic solid tumors II Determine the dose limiting toxicity of paclitaxel when combined with cisplatin and irinotecan in this patient population III Establish the recommended phase II dose for this regimen in this patient population IV Assess the antitumor activity of this regimen in selected solid tumor malignancies
OUTLINE This is a dose escalation study of paclitaxel All patients receive paclitaxel IV over 1 hour then cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes weekly for 4 weeks on days 1 8 15 and 22 Treatment is repeated every six weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of paclitaxel If 2 or more patients experience dose limiting toxicity DLT at a particular dose level escalation ceases and the maximum tolerated dose MTD is defined as the previous dose level Patients are followed until death
PROJECTED ACCRUAL Approximately 12-27 patients will be accrued for this study within 6-9 months
OUTLINE This is a dose escalation study of paclitaxel All patients receive paclitaxel IV over 1 hour then cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes weekly for 4 weeks on days 1 8 15 and 22 Treatment is repeated every six weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of paclitaxel If 2 or more patients experience dose limiting toxicity DLT at a particular dose level escalation ceases and the maximum tolerated dose MTD is defined as the previous dose level Patients are followed until death
PROJECTED ACCRUAL Approximately 12-27 patients will be accrued for this study within 6-9 months
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-G99-1495 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066860 | REGISTRY | None | None |