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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Sanofi-Synthelabo |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00508872 |
Purpose
Objective:
Primary Objective:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Liver Metastases |
Drug: 5-Fluorouracil Drug: Bevacizumab Drug: Leucovorin Drug: Oxaliplatin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 2 |
| Study Start Date: | November 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
FOLFOX-B: 5-Fluorouracil + Bevacizumab + Leucovorin + Oxaliplatin
|
Drug: 5-Fluorouracil
400 mg/m^2 IV Over 15 Minutes, followed by 2400 mg/m^2 IV Over 46 Hours
Drug: Bevacizumab
5 mg/kg IV Over 30-90 Minutes On Day 1 Every 14 Days
Drug: Leucovorin
400 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
Drug: Oxaliplatin
85 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
|
Hide Detailed DescriptionOxaliplatin 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.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will be asked questions about your medical history and have a complete physical exam. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will have a chest x-ray or computed tomography (CT) scan of the chest, CT scan of the abdomen (stomach) and pelvis (waist area), and a positron emission tomography (PET) scan. Women who are able to have children must have a negative blood-pregnancy test.
If you have not had a biopsy to confirm diagnosis of metastasis (spreading) of the cancer, a biopsy will be done. For this procedure, a thin needle will be inserted into the tumor in the liver after a local anesthesia has been given at the site of needle insertion. The procedure should take about 1 hour and you will be closely monitored for any pain. You will also have your vital signs (blood pressure, breathing, temperature, and heart rate) monitored for up to 4 hours after the procedure. A similar biopsy of a non-cancerous portion of your liver will be done to be sure that it is normal.
If you are found to be eligible to take part in this study, you may begin treatment.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Eddie Abdalla, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Eddie Abdalla, MD/Assistant Professor ) |
| Study ID Numbers: | 2004-0816 |
| Study First Received: | July 27, 2007 |
| Last Updated: | August 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00508872 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Colorectal Liver Metastases Oxaliplatin Eloxatin Fluorouracil Leucovorin Bevacizumab |
Anti-VEGF monoclonal antibody rhuMAb-VEGF Folfox-B 5-FU Avastin |
|
Antimetabolites Liver Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Bevacizumab Antibodies, Monoclonal Liver Neoplasms Oxaliplatin Neoplastic Processes Neoplasms by Site Pathologic Processes |
Therapeutic Uses Vitamins Neoplasm Metastasis Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil |