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Treatment Name: FOLFOX + Cetuxi­mab (Erbitux®)

FOLFOX + Cetuxi­mab (Erbitux®) is a Chemotherapy Regimen for Colon Cancer

How does FOLFOX + Cetuximab work?
Each chemotherapy drug in FOLFOX is designed to kill cancer cells. Cetuximab is designed to bind to the surface of cancer cells and shut down one of the signals that tell the cell to grow.

FOL - folinic acid (Leucovorin) (Note: Folinic acid and folic acid are NOT the same)
F - fluorouracil (5-FU)
OX - Oxaliplatin (Eloxatin®)
+
Cetuximab (Erbitux®)

Goals of therapy:
FOLFOX + Cetuximab is given to shink tumors, help decrease symptoms in a colon cancer patient, and to extend survival. It is not commonly given with the goal of cure.

Schedule

  • Folinic acid (Leucovorin) intravenous (I.V.) infusion, given over two hours before fluorouracil on Day 1
  • Oxaliplatin I.V. given over two hours on Day 1. This is commonly given at the same time as folinic acid (Leucovorin).
  • Fluorouracil (5-FU) I.V. push, usually given over 3 to 5 minutes on Day 1
  • Fluorouracil (5-FU) continuous I.V. infusion (via home-infusion pump) over 46 hours beginning Day 1 and ending on Day 2
  • Cetuximab I.V. given over two hours on Day 1 of Cycle 1, then over one hour every week starting a week after the first dose

Estimated total clinic infusion time for this treatment:

  • When all medications are given on the same day: Up to 5 hours for Cycle 1, Day 1. If the first treatment is tolerated well, infusion time can be as short as 4 hours for the first day of next cycles
  • On days when just cetuximab is given, infusion time can take as little as two hours
  • Some doctors may choose to give cetuximab every two weeks with the FOLFOX part of the treatment instead of weekly, this requires doubling the dose. This may be chosen to decrease infusion center visits to just every two weeks
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and I.V. fluids, such as hydration, may add more time

FOLFOX + cetuximab is usually given in an outpatient health care infusion center, allowing the person to go home afterwards where they will continue to receive their continuous 5-FU infusion via ambulatory pump.

The FOLFOX portion of the treatment is repeated every 14 days and cetuximab is given once every week. Each 14-day period is known as one Cycle. Each cycle may be repeated until the treatment no longer works or until unacceptable side effects occur. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.

Click here for the common FOLFOX + cetuximab starting doses.

Side Effects

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most common side effects reported for FOLFOX + cetuximab are shown here:

  • Diarrhea, (84%, severe 8%)
  • Weakness, (56%)
  • Rash, (53%, severe 11%)
  • Low white blood cells, (44%)
  • Mouth sores, (44%)
  • Tingling or numbness in finger and toes, (40%)
  • Altered sense of touch, (37%)
  • Loss of appetite, (35%)
  • Vomiting, (35%)
  • Abdominal pain, (30%)
  • Fingernail infection, (28%)
  • Acne, (23%)
  • Shortness of breath, (16%)
  • Infusion-related reaction, (16%)
  • Increased bleeding risk [low platelet count; thrombocytopenia], (4%)
  • Fatigue, severe, (4%)
  • Severe ulceration on hands or feet [hand-foot syndrome], (4%)
  • Anemia [Very low red blood cells], (4%)

Roughly 7 - 14% of patients discontinue all treatment due to unacceptable side effects. However, approximately 7% discontinue cetuximab only, while 28% discontinue FOLFOX only, but then continue cetuximab.

Side effect videos Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue Nausea and VomitingNausea and VomitingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before each treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood magnesium and potassium levels, plus any others your doctor may order. CEA (carcinoembryonic antigen) may be checked every six weeks to monitor tumor response.

How often is imaging needed?
Imaging, such as computerized tomography (CT) scan and/or magnetic resonance imaging (MRI), is checked before treatment and during treatment at the discretion of your doctor.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue FOLFOX + cetuximab as planned, or delay treatment, or switch therapy.

In clinical studies, up to 80% of patients experienced a treatment delay due to the appearance of a side effect, such as skin rash.

ChemoExperts Tips

  • Patients will have an infusion pump strapped to their body for 2 days to allow fluorouracil (5-FU) to continuously infuse into a vein. After receiving folinic acid (leucovorin) and 5-fluorouracil bolus dose in the infusion center, the I.V. line for continuous infusion fluorouracil is then connected by a nurse and the patient may go home. When the two-day fluorouracil infusion is finished, the patient goes back to the infusion center or hospital to have it disconnected, unless a home health nurse can come to the patient’s home to do this
  • Oxaliplatin can make you very sensitive to cold things such as cold drinks or cold weather for a few days after receiving treatment. It is best to wear warm clothes in cold weather and to not drink cold liquids, especially those with ice, or hold cold objects in your hands for up to 2 days after each oxaliplatin infusion
  • Fluorouracil may cause painful redness, blistering, and peeling skin reaction on the palms of your hands and on the soles of your feet. This is known as Hand-Foot Syndrome. Ways to help reduce the risk of experiencing Hand-Foot Syndrome include using a non-alcoholic moisturizer daily on your hands and feet, avoid wearing gloves, avoid prolonged exposure to hot water, and avoid activities that put pressure or friction on your hands and feet such as golf or tennis while receiving fluorouracil
  • The first dose of cetuximab is the dose most likely to cause an infusion reaction, which may include: fever, shaking, chills, and shortness of breath; the incidence of this is very low, 2% or less. Even if medications are given beforehand this can happen. Side effects generally go away when the infusion is stopped. It may be restarted at a slower rate. Most patients are able to receive the entire dose, although it may take longer than expected
  • Development of a skin rash is common while on cetuximab however, development of skin rashes may be linked with better disease response from this drug. Mild skin rashes can be treated with topical or oral antibiotics that are prescribed by your doctor. More severe rashes may be able to be treated with oral medications. Tell your doctor about any skin reactions
  • Avoid excess sun exposure while receiving cetuximab and up to 2 months after the last dose
  • Before each infusion, you may receive an antihistamine such as diphenhydramine (Benadryl®) to help prevent reactions. If possible, have someone drive you to and from these appointments as diphenhydramine can make you sleepy and have difficulty driving
  • Cetuximab may cause changes to fingernails and toenails such as redness, swelling, oozing, bleeding, cracking, discoloration, or ridges in the nails. This is known as “paronychia”. This can first develop weeks or months after starting therapy with cetuximab and can last for months after therapy is stopped. To help prevent paronychia from developing, avoid wearing tight fitting shoes or gloves and avoid putting unnecessary pressure or friction on fingernails and toenails. If you experience symptoms of paronychia, talk with your doctor as prescription corticosteroid creams or antibiotics may be needed
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Cetuximab may decrease your blood levels of potassium and/or magnesium. You may need to receive fluids into the vein containing magnesium and potassium. These infusions can increase your time at the infusion center by one to four hours depending on the dose
  • Clinical trials may exist for colon cancer treatment and cancer research. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for FOLFOX + Cetuxi­mab (Erbitux®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for FOLFOX + Cetuxi­mab (Erbitux®). Depending upon your income, they may be able to help cover the cost of:

  • Folinic acid
  • Fluorouracil
  • Oxaliplatin
  • Cetuximab

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as FOLFOX + Cetuxi­mab (Erbitux®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with FOLFOX + Cetuxi­mab (Erbitux®)

Individual Drug Label Information

Folinic acid (Leucovorin)

  • Folinic acid is an intravenous (I.V.) drug that is a derivative of folic acid, also known as vitamin B9
  • Is clear to slightly yellow in color
General Folinic Acid (Leucovorin) Side Effects
  • Seizures and fainting have been rarely reported
  • Click on the Folinic Acid (Leucovorin) package insert for all reported side effects and possible drug interactions
See DailyMed package insert.

Fluorouracil (Adrucil®)

  • Fluorouracil (5-FU) Is an intravenous (I.V.) drug
  • Recommended to be given only under the supervision of a qualified physician well versed in administering chemotherapy
General Fluorouracil (5-FU, Adrucil) Side Effects
  • Low white blood cell count (leucopenia and neutropenia)
  • Mouth and throat sores or ulcers (mucositis)
  • Diarrhea
  • Nausea and vomiting
  • Low red blood cell and platelet counts
  • Allergic reactions, rarely
  • Eye pain, light sensitivity, excess watering, visual changes
  • Headache
  • Skin conditions:  dryness, redness, tingling, light sensitivity, pain, swelling, loss of nails (hand-foot syndrome)
  • Dosage adjustments may be required for severe liver dysfunction
  • Click on the Fluorouracil (5-FU, Adrucil) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPainNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

Oxaliplatin (Eloxatin®)

  • Oxaliplatin is an intravenous (I.V.) drug
  • Allergic reactions have been reported and may occur within minutes. Certain drugs can be given to alleviate the symptoms: antihistamines, corticosteroids, or epinephrine
  • Oxaliplatin is usually diluted in a dextrose 5% I.V. bag and infused over 2 hours
  • Dosage adjustments may be required for liver dysfunction
General Oxaliplatin (Eloxatin) Side Effects
  • Nerve pain or tingling in feet and hands, loss of tendon reflexes
  • Oxaliplatin can make you very sensitive to cold things such as cold drinks or cold weather for a few days after receiving oxaliplatin. It is best to wear warm clothes in cold weather and to not drink cold liquids, especially those with ice, or hold cold objects in your hands for up to 2 days after each oxaliplatin infusion
  • Lung toxicity:  avoid with certain lung conditions
  • Low white blood cells, platelets, and red blood cells
  • Constipation
  • Diarrhea
  • Vomiting or nausea
  • Fatigue
  • Mouth sores
  • Change in liver function
  • Avoid during pregnancy, known to cause fetal harm
  • Click on the oxaliplatin (Eloxatin) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPain

See DailyMed package insert.

Cetuximab (Erbitux®)

  • Cetuximab is an intravenous infusion given over one to two hours
  • Severe infusion reactions such as difficulty breathing, low blood pressure, and heart problems can occur. You will receive medications before each dose of cetuximab to lower your risk of experiencing these reactions
  • Heart attack (cardiac arrest) can occur due to blood electrolyte abnormalities.  Your blood electrolytes (potassium, magnesium, and calcium) will usually be checked before each dose of cetuximab
  • Dosage adjustments may be required for serious skin reactions or other toxicities
  • Cetuximab does not have any drug interactions, but it does boost the effect of platinum drugs and radiation therapy
General Cetuximab (Erbitux) Side Effects
  • Skin reactions, acne-like rash and dry skin
  • Mouth sores
  • Difficult swallowing, painful swallowing
  • Dry mouth
  • Throat pain
  • Shortness of breath
  • Weight loss
  • Dehydration
  • Nausea 
  • Infection
  • Weakness and fatigue
  • Decrease in blood magnesium, potassium, or calcium levels
  • Diarrhea
  • Headache
  • Click on the cetuximab (Erbitux) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPain

See DailyMed package insert.

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References

1) Tabernero J, Van Cutsem E, Díaz-Rubio E, et al. Phase II trial of cetuximab in combination with fluorouracil, leucovorin, and oxaliplatin in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2007;25:5225-5232.

2) Bokemeyer C, Bondarenko I, Makhson A, et al. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2009;27:663-671.

3) Pinto C, Barone CA, Girolomoni G, et al. Management of Skin Toxicity Associated with Cetuximab Treatment in Combination with Chemotherapy or Radiotherapy. Oncologist. 2011;16:228-238.

Created: January 11, 2017 Updated: August 28, 2018

What is Colon Cancer?

A disease of the cells from the large intestine.  Colon cancer is the third most common cancer among both men and women.  Known causes include:  family history, poor diet, sedentary lifestyle, obestity, diabetes, history of colon polyps, smoking, heavy alcohol use, prior radiation treatment to abdomen for other cancers, and old age.  The stage can vary at diagnosis and throughout treatment.  Stages of colon cancer use Tumor, Node, Metastasis (TNM) staging as well as Stage Grouping using Stages I, II, III, or IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common FOLFOX + Cetuximab starting doses

  • Folinic acid (Leucovorin) 400 mg/m2 intravenous infusion (I.V.) over two hours, before fluorouracil bolus, Day 1
  • Oxaliplatin 85 mg/m2 I.V. over two hours on Day 1
  • Fluorouracil 400 mg/m2 I.V. push over 3 to 5 minutes on Day 1
  • Fluorouracil 2400 mg/m2 continuous I.V. infusion (via home-infusion pump) over 44 - 46 hours beginning Day 1 and ending on Day 2
  • Cetuximab 400 mg/m2 I.V. over two hours on Day 1 of Cycle 1, then Cetuximab 250 mg/m2 over one hour every week thereafter

    Note:
    Individual doses may vary based upon your Doctor's recommendation, or drug availability

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1) Tabernero J, Van Cutsem E, Díaz-Rubio E, et al. Phase II trial of cetuximab in combination with fluorouracil, leucovorin, and oxaliplatin in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2007;25:5225-5232.

2) Bokemeyer C, Bondarenko I, Makhson A, et al. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2009;27:663-671.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is Leucovorin?

Leucovorin is not a chemotherapy agent. It is a special form of folic acid (vitamin B9) that helps increase the effectiveness of fluorouracil. Folic acid should NOT be confused with leucovorin (foliNic acid) as it does not work the same way.