Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215501
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2005-09-14
Brief Title:
Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Trial of Capecitabine or Continuous Infusion 5-Fluorouracil in Combination With Weekly Irinotecan and Cisplatin in Patients With Advanced Solid Tumor Malignancies
Status:
COMPLETED
Status Verified Date:
2018-10
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 test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects good and bad these have on patients with unresectable advanced solid tumors
Detailed Description:
This is a Phase I dose escalation study The dose of drug the patient receives will be assigned based upon when they enter the study Since we are looking for the highest dose of capecitabine or 5-fluorouracil that can be given safely in combination with cisplatin and irinotecan not everyone who participates in this study will be receiving the same amount of the drug
There are four parts to this study 1Choice of treatment 2Evaluation 3Chemotherapy and 4Follow-up
The patient and the patients doctor will decide which form of chemotherapy is best for the patient either pill form or continuous infusion Chemotherapy pills capecitabine are given twice per day for 14 days is a row every 3 weeks Continuous infusion 5-fluorouracil is given through a pump 24 hours a day for 14 days every 3 weeks
Prior to initiation to therapy the extent of the patients cancer will be evaluated This includes a CT scan chest x-ray EKG and bloodwork
Patients will receive chemotherapy for 2 weeks followed by a one week break This will constitute one cycle The medications cisplatin and irinotecan will be given intravenously on the 1st and 8th day of each cycle Following the rest period the next cycle of chemotherapy begins
Following 2 cycles of chemotherapy the patients cancer will be re-evaluated A CT scan and bloodwork will be obtained and will be compared to the previous studies Treatment will resume if the cancer is the same size or smaller than before and the patient is tolerating the chemotherapy well The cancer will be re-evaluated every 2 cycles of chemotherapy
There are four parts to this study 1Choice of treatment 2Evaluation 3Chemotherapy and 4Follow-up
The patient and the patients doctor will decide which form of chemotherapy is best for the patient either pill form or continuous infusion Chemotherapy pills capecitabine are given twice per day for 14 days is a row every 3 weeks Continuous infusion 5-fluorouracil is given through a pump 24 hours a day for 14 days every 3 weeks
Prior to initiation to therapy the extent of the patients cancer will be evaluated This includes a CT scan chest x-ray EKG and bloodwork
Patients will receive chemotherapy for 2 weeks followed by a one week break This will constitute one cycle The medications cisplatin and irinotecan will be given intravenously on the 1st and 8th day of each cycle Following the rest period the next cycle of chemotherapy begins
Following 2 cycles of chemotherapy the patients cancer will be re-evaluated A CT scan and bloodwork will be obtained and will be compared to the previous studies Treatment will resume if the cancer is the same size or smaller than before and the patient is tolerating the chemotherapy well The cancer will be re-evaluated every 2 cycles of chemotherapy
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