A Phase 2 interventional study of 5-Fluorouracil and Bevacizumab in Colorectal Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-21.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
Objectives:
Colorectal cancer growth may be affected by a protein in the body called "vascular endothelial growth factor" (VEGF). A drug that blocks VEGF may be an effective treatment for colorectal cancer. Bevacizumab is designed to block VEGF. Bevacizumab will be added to 5-Fluorouracil (5-FU), leucovorin (LV), and irinotecan, a drug combination routinely used in the treatment of advanced colorectal cancer.
Before you can start treatment on the 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 about any medications you are currently taking or have taken in the past. You will have a complete physical exam and your heart rate, temperature, breathing rate, blood pressure, height, and weight will be measured. You will be asked about your ability to perform every day activities. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will have a chest x-ray and scans (either computed tomography (CT) or magnetic resonance imaging (MRI)) of your abdomen and pelvis to evaluate the cancer. Scans of other parts of your body also may be taken if your doctor thinks they are needed to evaluate your cancer. Blood (about 3 tablespoons) and urine samples will be collected for routine tests, including complete blood count, carcinoembryonic antigen (CEA) level (a marker for your cancer), and chemistry profile. Women who are able to have children must have a negative blood or urine pregnancy test
If the screening evaluations show you are eligible to take part in the study, you may begin treatment Study treatment is repeated every 2 weeks (14 days). Each 14-day period of treatment is called a "cycle" of therapy. You must receive study treatment at M. D. Anderson.
All study drugs will be given through a needle into a vein. For your first treatment, you will receive bevacizumab alone first. The first dose of bevacizumab will be given over about 90 minutes. If you do not have a reaction (such as fever/chills), the next dose will be given over about 60 minutes, and if again no reaction occurs, each dose after that will be given over about 30 minutes. If you experience a reaction to the bevacizumab infusion, you may be given acetaminophen (such as Tylenol) by mouth and/or an antihistamine by vein over 30 minutes before each dose to help decrease the risk of further reactions.
Fourteen (14) days later and for all future cycles, you will receive bevacizumab, LV, and irinotecan given on Day 1 of each cycle. 5-FU is given over 46 hours over Days 1-3.
Bevacizumab will be given as described above. When the bevacizumab infusion ends, you will receive LV and irinotecan, starting at the same time. You will receive irinotecan over 90 minutes and LV over 2 hours. When the LV infusion ends, 5-FU will be given over 2 to 4 minutes. This is followed by more 5-FU given over 46 hours using a small portable pump (about the size of a standard paperback book).
Before each new cycle of study treatment, you will be asked questions about any side effects you may have had and about any medications you are currently taking or have taken since you last saw the study doctor. You will have a complete physical exam, including measurements of blood pressure, pulse, temperature, and weight. You will be asked about your ability to perform every day tasks. About 3 tablespoons of blood will be taken for routine laboratory tests. These tests include a complete blood count and chemistry profile. A urine sample will be taken before every other cycle of treatment. During the first cycle of treatment, on Day 8, you will have a sample of blood (about 3 teaspoons) drawn. This test may be done at a lab close to your home.
You will also have either CT scans or MRI of the tumor(s) every 8 weeks and at the end of the study treatment. About 1 tablespoon of blood will be taken to check your CEA level at the same time scans are done. Additional tests may be done during the study if your doctor feels it is necessary for your care. Except for the weekly blood test, which may be done at a lab close to home, all testing and evaluations must be done at M. D. Anderson.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive study treatment unless the disease gets worse, you decide not to take part any longer, or your doctor decides it is in your best interest to stop treatment.
When you stop study treatment, you will be asked to have some tests and evaluations done at an end of study visit. Urine and about 3 tablespoons of blood will be taken for routine laboratory tests, including complete blood count, CEA level, and chemistry profile. You will also have a physical exam. CT scan or MRI scan of your abdomen and pelvis will also be done to check the size and location of your disease.
Once you stop receiving study treatment, the study doctor or nurse will continue to check how you are doing, either in the clinic or by telephone if you stop coming to M. D. Anderson, every 3 months for the rest of your life.
This is an investigational study. The drugs used in this study are approved by the FDA for treatment of advanced colorectal cancer. Up to 43 patients will take part in this multicenter study. About 38 will be enrolled at M. D. Anderson.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 49 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FOLFIRI \[folinic acid (leucovorin) 400 mg/m\^2 by vein (IV) Day 1; 5-FU 400 mg/m\^2 IV injection Day 1 immediately followed by 2.4 g/m\^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m\^2 IV on Day 1\] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
Drug: 5-Fluorouracil · Drug: Bevacizumab · Drug: Leucovorin · Drug: Irinotecan
400 mg/m\^2 injection by vein Day 1 of 14 day cycle immediately after completion of leucovorin infusion. 2.4 g/m\^2 by vein over 46 hours over Days 1-3 of 14 day cycle immediately after completion of 400 mg/m\^2 injection.
Also known as: F of FOLFIRI, 5-FU, Adrucil, Efudex
5 mg/kg over 90 minutes on Day 1 of first 14 day cycle as initial dose, administered alone without other drugs. 5 mg/kg by vein on Day 1 of 14 day cycle.
Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
400 mg/m\^2 over 2-4 minutes by vein on Day 1 of 14 day cycle.
Also known as: FOL of FOLFIRI, LV, folinic acid
180 mg/m\^2 by vein over 90 minutes on Day 1 of 14 day cycle.
Also known as: IRI of FOLFIRI, CPT-11
Median Progression-free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.
Time frame: From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 months
Recruitment Period: January 13, 2005 through January 31, 2007. All recruitment done at UT MD Anderson Cancer Center.
| Milestone | FOLFIRI Plus Bevacizumab |
|---|---|
| Started | 43 |
| Completed | 43 |
| Not completed | 0 |
PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.
| Months | FOLFIRI Plus Bevacizumab |
|---|---|
| Median Progression-free Survival (PFS) | 12.8 ± .02 |
Collected over 3 years and 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FOLFIRI Plus Bevacizumab | — | 0/43 (0%) | 43/43 (100%) |
| Event | FOLFIRI Plus Bevacizumab |
|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 22/43 |
| FatigueGeneral disorders | 19/43 |
| HemoglobinBlood and lymphatic system disorders | 19/43 |
| Hemorrhage, Pulmonary (Nose)Respiratory, thoracic and mediastinal disorders | 19/43 |
| NauseaGastrointestinal disorders | 19/43 |
| Serum Glutamic Oxaloacetic Transaminase (AST)General disorders | 18/43 |
| VomitingGastrointestinal disorders | 16/43 |
| Neutrophils/Granulocytes (ANC/AGC)Metabolism and nutrition disorders | 14/43 |
| Pain (Muscle)General disorders | 12/43 |
| Watery EyeEye disorders | 12/43 |
| Age Continuous(years) | FOLFIRI Plus Bevacizumab |
|---|---|
| Median | 57 (26 to 78) |
| Sex: Female, Male(Participants) | FOLFIRI Plus Bevacizumab |
|---|---|
| Female | 17 |
| Male | 26 |
| Region of Enrollment(participants) | FOLFIRI Plus Bevacizumab |
|---|---|
| United States | 43 |
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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