Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436072
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2007-02-15
Brief Title:
ZD6474 Cetuximab and Irinotecan in Patients With Metastatic Colorectal Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase I Study of ZD6474 Cetuximab and Irinotecan in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
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:
This research study will test the safety of the investigational drug ZD6474 in combination with 2 other drugs that are standard in the treatment of colon and rectal cancer cetuximab and irinotecan ZD6474 blocks the action of two substances in the body vascular endothelial growth factor receptor VEGFR and epidermal growth factor receptor EGFR VEGFR stimulates the formation of new blood vessels When cancer cells produce VEGFR new blood vessels are made that provide blood to the cancer cells The blood carries nutrients and oxygen allowing the cancer cells to live and grow EGFR controls how quickly cells grow and multiply Both of these substances are found on normal cells but they are found in much higher levels on cancer cells
Detailed Description:
The main purpose is to find the highest dose of ZD6474 that is safe to give in combination with cetuximab and irinotecan We will also be collecting information on how the body responds to the study drugs and what effects good or bad it has on treatment of colon and rectal cancer
Initially we plan to add ZD6474 to cetuximab alone Small groups of participants will be enrolled in steps The first group will be given a certain dose of ZD6474 and cetuximab If the participants have few or manageable side effects the next small group of people will receive a higher dose of ZD6474 This increase will continue until the study doctors find the highest dose that can be given
Once we determine the highest dose of ZD6474 with cetuximab we will add irinotecan at increasing doses to determine the safety of all three drugs combined The participant will know whether they are receiving the two or three drug combination
In order to confirm the safety of combining these drugs and to understand more how they work and interact with each other some participants on this study will take just the ZD6474 for 2 weeks prior to starting the cetuximab andor irinotecan
Each cycle of treatment is 8 weeks long All participants will start taking ZD6474 orally on day one and continue taking it at home thereafter Cetuximab and irinotecan are given intravenously Cetuximab is given once a week Irinotecan will be given to participants that enter the trial once the safe dose of ZD6474 and cetuximab is determined Irinotecan is given on Day 15 of cycle one then every other week
Participants will be asked to visit the clinic every week for the first three weeks they are on the study After the first three weeks they will be required to visit with the doctor every other week These visits will include physical exams routine blood tests scans and other tests or procedures to monitor health
In addition to routine blood tests blood tests for research will be done on the last 10 subjects on the trial Test results from this sample will be used to evaluate the participants condition
In order to be treated on this study a tumor tissue specimen must ba available for research testing The specimen will be taken from a biopsy that was done before the participant enrolled on the study
Participants can continue on the study drug as long as they tolerate the drug and the cancer does not grow
Initially we plan to add ZD6474 to cetuximab alone Small groups of participants will be enrolled in steps The first group will be given a certain dose of ZD6474 and cetuximab If the participants have few or manageable side effects the next small group of people will receive a higher dose of ZD6474 This increase will continue until the study doctors find the highest dose that can be given
Once we determine the highest dose of ZD6474 with cetuximab we will add irinotecan at increasing doses to determine the safety of all three drugs combined The participant will know whether they are receiving the two or three drug combination
In order to confirm the safety of combining these drugs and to understand more how they work and interact with each other some participants on this study will take just the ZD6474 for 2 weeks prior to starting the cetuximab andor irinotecan
Each cycle of treatment is 8 weeks long All participants will start taking ZD6474 orally on day one and continue taking it at home thereafter Cetuximab and irinotecan are given intravenously Cetuximab is given once a week Irinotecan will be given to participants that enter the trial once the safe dose of ZD6474 and cetuximab is determined Irinotecan is given on Day 15 of cycle one then every other week
Participants will be asked to visit the clinic every week for the first three weeks they are on the study After the first three weeks they will be required to visit with the doctor every other week These visits will include physical exams routine blood tests scans and other tests or procedures to monitor health
In addition to routine blood tests blood tests for research will be done on the last 10 subjects on the trial Test results from this sample will be used to evaluate the participants condition
In order to be treated on this study a tumor tissue specimen must ba available for research testing The specimen will be taken from a biopsy that was done before the participant enrolled on the study
Participants can continue on the study drug as long as they tolerate the drug and the cancer does not grow
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