Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291486
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2006-02-10
Brief Title:
Capecitabine and 131I-huA33 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 Oral Capecitabine Combined With 131I-huA33 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:
The purpose of this clinical trial is to determine whether it is safe to treat patients with advanced colorectal cancer with humanised A33 antibody tagged with radioactive iodine 131I-huA33 in combination with chemotherapy capecitabine
Detailed Description:
This clinical trial tests the combination of humanised A33 monoclonal antibody tagged with radioactive iodine 131 131I-huA33 together with capecitabine chemotherapy in patients with advanced colorectal cancer
When colorectal cancer has spread to other organs it is generally considered incurable but with a limited number of treatment options Colorectal cancer cells express proteins on their surface known as antigens and one of these is called the A33 antigen An antibody which targets the A33 antigen was initially developed in the mouse and found to bind to human colorectal cancer cells Because humans developed immune reactions when given the mouse antibody an antibody which is more like normal human antibodies was developed humanised A33 antibody In order to increase its effectiveness radioactive iodine 131I has been attached to the antibody so that the antibody can deliver radiation directly to colorectal cancer cells Previous studies have shown that both the unlabelled humanised A33 antibody as well as the humanised A33 antibody tagged with radioactive iodine can be administered safely to humans with no major allergic reactions The addition of chemotherapy to radiolabelled 131I-huA33 may result in a treatment that is more effective for the treatment of colorectal cancer than either agent alone
The purpose of this study is to determine whether it is safe to give humanised A33 antibody tagged with radioactive iodine together with chemotherapy Different dose levels of radioactive iodine attached to a constant dose of antibody will be given together with a fixed total daily capecitabine chemotherapy dose Providing humanised A33 antibody tagged with radioactive iodine and chemotherapy is tolerated well without major side effects the dose of capecitabine chemotherapy given with 131I-huA33 will also be increased in order to determine the highest dose that can be given safely in combination with radio-labelled 131I-huA33 The effectiveness of the treatment combination against advanced colorectal cancer will also be assessed
Patients with advanced colorectal cancer who have never previously received chemotherapy using capecitabine may be eligible to participate in the study A total of between 15 and 30 patients are expected to be recruited
Screening blood tests will be performed to determine eligibility as well as baseline heart and lung function tests and appropriate scans to measure tumour size and assess radiation within the body Patients will be given a trace-labelled small radiation dose infusion of 131I-huA33 into a vein followed a week later by the treatment infusion of 131I-huA33 The first infusion will be given as an outpatient but for the second patients will be hospitalized and confined to a radiation-shielded room until radiation levels fall to safe limits Oral iodine drops will also be given for 28 days in order to protect the thyroid gland from the effects of radioactive iodine Capecitabine chemotherapy will be taken orally and will commence at the time of the treatment infusion Each cycle of capecitabine chemotherapy involves the medication being taken twice per day for a total of 14 days followed by 7 days rest A total of 4 cycles of capecitabine will be given after the treatment infusion
Blood samples will be taken just before the treatment infusion and then weekly for 13 weeks There will be weekly physical examinations until 9 weeks after the treatment infusion and again at 12 weeks Total study duration is 13 weeks from the trace-labelled infusion of 131I-huA33 that is 12 weeks from the treatment infusion of 131I-huA33 Patients will only receive one treatment infusion of 131I-huA33 antibody
When colorectal cancer has spread to other organs it is generally considered incurable but with a limited number of treatment options Colorectal cancer cells express proteins on their surface known as antigens and one of these is called the A33 antigen An antibody which targets the A33 antigen was initially developed in the mouse and found to bind to human colorectal cancer cells Because humans developed immune reactions when given the mouse antibody an antibody which is more like normal human antibodies was developed humanised A33 antibody In order to increase its effectiveness radioactive iodine 131I has been attached to the antibody so that the antibody can deliver radiation directly to colorectal cancer cells Previous studies have shown that both the unlabelled humanised A33 antibody as well as the humanised A33 antibody tagged with radioactive iodine can be administered safely to humans with no major allergic reactions The addition of chemotherapy to radiolabelled 131I-huA33 may result in a treatment that is more effective for the treatment of colorectal cancer than either agent alone
The purpose of this study is to determine whether it is safe to give humanised A33 antibody tagged with radioactive iodine together with chemotherapy Different dose levels of radioactive iodine attached to a constant dose of antibody will be given together with a fixed total daily capecitabine chemotherapy dose Providing humanised A33 antibody tagged with radioactive iodine and chemotherapy is tolerated well without major side effects the dose of capecitabine chemotherapy given with 131I-huA33 will also be increased in order to determine the highest dose that can be given safely in combination with radio-labelled 131I-huA33 The effectiveness of the treatment combination against advanced colorectal cancer will also be assessed
Patients with advanced colorectal cancer who have never previously received chemotherapy using capecitabine may be eligible to participate in the study A total of between 15 and 30 patients are expected to be recruited
Screening blood tests will be performed to determine eligibility as well as baseline heart and lung function tests and appropriate scans to measure tumour size and assess radiation within the body Patients will be given a trace-labelled small radiation dose infusion of 131I-huA33 into a vein followed a week later by the treatment infusion of 131I-huA33 The first infusion will be given as an outpatient but for the second patients will be hospitalized and confined to a radiation-shielded room until radiation levels fall to safe limits Oral iodine drops will also be given for 28 days in order to protect the thyroid gland from the effects of radioactive iodine Capecitabine chemotherapy will be taken orally and will commence at the time of the treatment infusion Each cycle of capecitabine chemotherapy involves the medication being taken twice per day for a total of 14 days followed by 7 days rest A total of 4 cycles of capecitabine will be given after the treatment infusion
Blood samples will be taken just before the treatment infusion and then weekly for 13 weeks There will be weekly physical examinations until 9 weeks after the treatment infusion and again at 12 weeks Total study duration is 13 weeks from the trace-labelled infusion of 131I-huA33 that is 12 weeks from the treatment infusion of 131I-huA33 Patients will only receive one treatment infusion of 131I-huA33 antibody
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA108145-01A1 | NIH | None | httpsreporternihgovquickSearchR21CA108145-01A1 |