Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251407
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
2005-11-08
Brief Title:
Taxotere Cisplatin and CPT-11 in Advanced Solid Tumor Malignancies
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase I Study of Taxotere Cisplatin and CPT-11 in Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2012-08
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:
The purpose of this study is to find the highest dose of the combination of taxotere cisplatin and CPT-11 that can be given without causing severe side effects We also want to test the safety of this drug combination and see what effects good and bad it has on patients with advanced cancer for which there is no known curable treatment
Detailed Description:
This is a Phase I clinical trial We are unsure of the safest and most effective dose of the drugs and therefore are planning on treating 3-6 patients with a given dose before increasing to higher dose levels
Each patient will receive approximately two cycles of therapy On day one and day eight they will receive taxotere cisplatin and CPT-11 intravenously The cycle will begin again on day 22
The following tests and procedures will be performed CAT scan prior to beginning therapy after every 2 cycles of therapy and at the end of the study physical exam before each course of therapy vital signs before and with each dose of therapy routine blood tests before starting therapy and weekly during treatment chest x-ray and echocardiogram before starting therapy and toxicity assessment each week of therapy
Patients will remain on the study as long as their cancer responds to treatment and they do not have unacceptable side effects
Each patient will receive approximately two cycles of therapy On day one and day eight they will receive taxotere cisplatin and CPT-11 intravenously The cycle will begin again on day 22
The following tests and procedures will be performed CAT scan prior to beginning therapy after every 2 cycles of therapy and at the end of the study physical exam before each course of therapy vital signs before and with each dose of therapy routine blood tests before starting therapy and weekly during treatment chest x-ray and echocardiogram before starting therapy and toxicity assessment each week of therapy
Patients will remain on the study as long as their cancer responds to treatment and they do not have unacceptable side effects
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