Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508872
Status:
TERMINATED
Last Update Posted:
2012-08-01
First Post:
2007-07-27
Brief Title:
Folfox-B Study for Patients With Colorectal Liver Metastases
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Single-Institution Phase II Trial of Oxaliplatin 5-Fluorouracil Leucovorin and Bevacizumab Folfox-B for Initially Unresectable Colorectal Liver Metastases Downstaging Followed By Hepatic Resection
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual study terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective
To evaluate the efficacy of the use of the combination of oxaliplatin 5-fluorouracil leucovorin and bevacizumab FOLFOX-B in patients with unresectable colorectal liver metastases with the objective to downstage hepatic disease and enable complete resection of residual disease
Primary Objective
To evaluate the resection rate in patients with initially unresectable hepatic colorectal metastases downstaged with FOLFOX-B Complete resection of all liver lesions is the goal
Secondary Objectives
To evaluate the probability of complete response partial response or stable disease
To evaluate the proportion of patients who are resected and the proportion of patients achieving an R0 resection among those receiving surgery
To correlate survival with downstaging and resection based on metastatic colorectal prognostic score
To evaluate the disease-free survival and overall survival
To evaluate the positron emission tomography response rate
To explore correlations of clinical response with telomerase and hTERT expression
To evaluate the efficacy of the use of the combination of oxaliplatin 5-fluorouracil leucovorin and bevacizumab FOLFOX-B in patients with unresectable colorectal liver metastases with the objective to downstage hepatic disease and enable complete resection of residual disease
Primary Objective
To evaluate the resection rate in patients with initially unresectable hepatic colorectal metastases downstaged with FOLFOX-B Complete resection of all liver lesions is the goal
Secondary Objectives
To evaluate the probability of complete response partial response or stable disease
To evaluate the proportion of patients who are resected and the proportion of patients achieving an R0 resection among those receiving surgery
To correlate survival with downstaging and resection based on metastatic colorectal prognostic score
To evaluate the disease-free survival and overall survival
To evaluate the positron emission tomography response rate
To explore correlations of clinical response with telomerase and hTERT expression
Detailed Description:
Oxaliplatin and bevacizumab are chemotherapy drugs that are designed to kill cancer cells 5-FU is a chemotherapy drug that helps to stop the growth of cancer cells Leucovorin is a drug that may help increase the effect of 5-FU
The study drugs will be given to you on an outpatient basis and will involve a minimum of 4 cycles and up to a maximum of 12 cycles of chemotherapy All chemotherapy will be given through a catheter placed in a vein in the shoulder in cycles Each cycle equals 14 days On the first day Day 1 of each cycle bevacizumab will be given for 30 to 90 minutes and oxaliplatin and leucovorin for 2 hours On Day 1 as well part of the total 5-FU dose will be given for 15 minutes through the catheter The rest of the 5-FU dose is then given through a pump over the next 46 hours After 46 hours you will have a rest period without drug treatment for the rest of the cycle until the start of the next cycle
Before each chemotherapy cycle you will have blood drawn about 2 tablespoons for tests to check for any side effects Depending on the results of the blood tests these blood tests may be done more often You will also have your vital signs blood pressure breathing temperature and heart rate monitored during the treatment You will be seen every 2 weeks by one of your doctors during your therapy
If at any time the disease gets worse or you experience any intolerable side effects you will be taken off the study
After completion of the 4th cycle of chemotherapy you will have a complete physical exam and routine blood tests about 2 tablespoons You will also have a CT scan of the abdomen and pelvis and a chest x-ray or CT scan of the chest These tests are being done to find out if the tumor can be removed by surgery
If your tumors cannot be removed at this time you will continue to receive the same dose of chemotherapy with the same tests for up to a maximum of 12 cycles If it is found that the tumor still cannot be removed after 12 cycles your participation in this study will be complete and your doctor will discuss other treatment options with you
If the tumor can be removed you will receive 1 additional cycle of oxaliplatin leucovorin and 5-FU no bevacizumab at the same doses before you go on to have the surgery Your surgery will be scheduled 8-12 weeks after the completion of chemotherapy The surgeon will explain the surgery and any risks During liver tumor surgery normal tissue around the edges of the tumor will be collected as part of routine care You will be asked to sign a separate consent form for the surgery Additional routine blood tests about 2 tablespoons and a PET scan will be done before surgery
If you have tumors removed around 28 days after the surgery you will be given 8 additional cycles of bevacizumab given the same way as before surgery
Around 4-6 weeks after the final chemotherapy treatment you will have follow-up CT scans of the abdomen and pelvis a chest x-ray or CT scan of the chest and a routine blood test about 2 tablespoons These tests will be repeated every 3 months for the first 3 years after surgery every 6 months for the 4th and 5th year after surgery and then once a year for the rest of your life PET scans will be done once a year to check on the status of the disease
This is an investigational study Oxaliplatin 5-FU leucovorin and bevacizumab are FDA approved and commercially available for the treatment of this disease However their use together in this study is investigational Up to 42 patients will take part in this study All will be enrolled at M D Anderson
The study drugs will be given to you on an outpatient basis and will involve a minimum of 4 cycles and up to a maximum of 12 cycles of chemotherapy All chemotherapy will be given through a catheter placed in a vein in the shoulder in cycles Each cycle equals 14 days On the first day Day 1 of each cycle bevacizumab will be given for 30 to 90 minutes and oxaliplatin and leucovorin for 2 hours On Day 1 as well part of the total 5-FU dose will be given for 15 minutes through the catheter The rest of the 5-FU dose is then given through a pump over the next 46 hours After 46 hours you will have a rest period without drug treatment for the rest of the cycle until the start of the next cycle
Before each chemotherapy cycle you will have blood drawn about 2 tablespoons for tests to check for any side effects Depending on the results of the blood tests these blood tests may be done more often You will also have your vital signs blood pressure breathing temperature and heart rate monitored during the treatment You will be seen every 2 weeks by one of your doctors during your therapy
If at any time the disease gets worse or you experience any intolerable side effects you will be taken off the study
After completion of the 4th cycle of chemotherapy you will have a complete physical exam and routine blood tests about 2 tablespoons You will also have a CT scan of the abdomen and pelvis and a chest x-ray or CT scan of the chest These tests are being done to find out if the tumor can be removed by surgery
If your tumors cannot be removed at this time you will continue to receive the same dose of chemotherapy with the same tests for up to a maximum of 12 cycles If it is found that the tumor still cannot be removed after 12 cycles your participation in this study will be complete and your doctor will discuss other treatment options with you
If the tumor can be removed you will receive 1 additional cycle of oxaliplatin leucovorin and 5-FU no bevacizumab at the same doses before you go on to have the surgery Your surgery will be scheduled 8-12 weeks after the completion of chemotherapy The surgeon will explain the surgery and any risks During liver tumor surgery normal tissue around the edges of the tumor will be collected as part of routine care You will be asked to sign a separate consent form for the surgery Additional routine blood tests about 2 tablespoons and a PET scan will be done before surgery
If you have tumors removed around 28 days after the surgery you will be given 8 additional cycles of bevacizumab given the same way as before surgery
Around 4-6 weeks after the final chemotherapy treatment you will have follow-up CT scans of the abdomen and pelvis a chest x-ray or CT scan of the chest and a routine blood test about 2 tablespoons These tests will be repeated every 3 months for the first 3 years after surgery every 6 months for the 4th and 5th year after surgery and then once a year for the rest of your life PET scans will be done once a year to check on the status of the disease
This is an investigational study Oxaliplatin 5-FU leucovorin and bevacizumab are FDA approved and commercially available for the treatment of this disease However their use together in this study is investigational Up to 42 patients will take part in this study All will be enrolled at M D Anderson
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