Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199797
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2005-09-12
Brief Title:
Phase I Trial of huA33 Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Phase I Trial of huA33 Plus 5-fluorouracil 5-FU Leucovorin and Oxaliplatin in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2022-10
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:
Although treatment for metastatic colorectal cancer has improved significantly over the recent years it still remains a significant health problem representing the leading cancer by incidence in the United States of America In the search for new therapies monoclonal antibodies have been developed to specifically target human colon cancer cells huA33 is an antibody that reacts with the A33 antigen which is produced by colorectal cancers Prior studies have shown that administration of the huA33 antibody may delay the growth of tumor cells producing the specific antigen Oxaliplatin and 5-fluorouracil 5-FU are cytotoxic agents which are considered as standard treatment in metastatic colorectal cancer Leucovorin folinic acid is a vitamin which enhances the effect of 5-FU Eligible patients with advanced colorectal cancer will receive huA33 10 mgm2 by intravenous IV infusion weekly for twelve weeks Starting on Study Day 15 week 3 5-FU leucovorin and oxaliplatin will be administered every 2 weeks for 10 weeks Patients will be evaluated weekly for toxicity Blood samples will be obtained every week for hematology and serum biochemistry analysis and for determination of human anti-human antibodies HAHA In patients with measurable disease tumors will be assessed by the appropriate scan at baseline and at the end of the thirteen week cycle The primary objective of this study is to assess the safety of huA33 5-FU leucovorin oxaliplatin The secondary objective is to measure the immunogenicity of huA33 when given in combination with 5-FU plus leucovorin and oxaliplatin and to document tumor responses
Detailed Description:
Purpose of the Research Study
huA33 is an antibody that reacts with the A33 antigen which is produced by colorectal cancers Prior studies have shown that application of the huA33 antibody may delay the growth of tumor cells producing the respective antigen
Oxaliplatin and 5-FU are cytotoxic agents which are considered as standard treatment in metastatic colorectal cancer Leucovorin is a vitamin which enhances the effect of 5-FU
The primary purpose of this study is to determine whether the combination huA33 plus oxaliplatin 5-FU and leucovorin is safe and what side effects occur
Description of Research Procedures
The first step is to determine whether or not patients are eligible for participation in the study Apart from general blood tests and x-ray studies needed this involves testing with regard to some special requirements
Three tests of stool to determine if it is positive for blood
Women of childbearing age must have a negative pregnancy test
If patients ever had a treatment with similar substances like huA33 before a blood sample needs to be tested for antibodies that may have developed against huA33
After eligibility is established huA33 will be administered intravenously over a period of 30 minutes once a week at a dose of 10 mgm2 Starting on day 15 and continuing every second week oxaliplatin 5-FU and leucovorin are administered Oxaliplatin and leucovorin will be given as infusions over 2 hours Afterwards patients will receive a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours
The doses of oxaliplatin will be 85mgm2 leucovorin 200mgm2 400mgm2 of 5-FU as a bolus infusion and 600mgm2 as a continuous infusion A complete treatment cycle consists of 12 weekly treatment days
Patients will have an interview with their doctor and a physical examination before the first day of treatment and before each therapy Standard blood tests as well as special blood tests to measure a possible reaction of the immune system to the huA33 antibody will be done weekly and before the treatment is started The amount of blood to be drawn will be 20-30 ml during one cycle of the study
X-rays andor CT scans to measure the extent of the disease will be done at the start and at week 13 which is considered to be the first day of the next cycle Patients may continue with this treatment for up to 2 cycles
huA33 is an antibody that reacts with the A33 antigen which is produced by colorectal cancers Prior studies have shown that application of the huA33 antibody may delay the growth of tumor cells producing the respective antigen
Oxaliplatin and 5-FU are cytotoxic agents which are considered as standard treatment in metastatic colorectal cancer Leucovorin is a vitamin which enhances the effect of 5-FU
The primary purpose of this study is to determine whether the combination huA33 plus oxaliplatin 5-FU and leucovorin is safe and what side effects occur
Description of Research Procedures
The first step is to determine whether or not patients are eligible for participation in the study Apart from general blood tests and x-ray studies needed this involves testing with regard to some special requirements
Three tests of stool to determine if it is positive for blood
Women of childbearing age must have a negative pregnancy test
If patients ever had a treatment with similar substances like huA33 before a blood sample needs to be tested for antibodies that may have developed against huA33
After eligibility is established huA33 will be administered intravenously over a period of 30 minutes once a week at a dose of 10 mgm2 Starting on day 15 and continuing every second week oxaliplatin 5-FU and leucovorin are administered Oxaliplatin and leucovorin will be given as infusions over 2 hours Afterwards patients will receive a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours
The doses of oxaliplatin will be 85mgm2 leucovorin 200mgm2 400mgm2 of 5-FU as a bolus infusion and 600mgm2 as a continuous infusion A complete treatment cycle consists of 12 weekly treatment days
Patients will have an interview with their doctor and a physical examination before the first day of treatment and before each therapy Standard blood tests as well as special blood tests to measure a possible reaction of the immune system to the huA33 antibody will be done weekly and before the treatment is started The amount of blood to be drawn will be 20-30 ml during one cycle of the study
X-rays andor CT scans to measure the extent of the disease will be done at the start and at week 13 which is considered to be the first day of the next cycle Patients may continue with this treatment for up to 2 cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None