Cancer Trials

Cancer Trials

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Capecitabine Oral tablet

What is this medicine?

CAPECITABINE (ka pe SITE a been) is a chemotherapy drug. It slows the growth of cancer cells. This medicine is used to treat breast cancer, and also colon or rectal cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • bleeding or blood disorders

  • dihydropyrimidine dehydrogenase (DPD) deficiency

  • heart disease

  • infection (especially a virus infection such as chickenpox, cold sores, or herpes)

  • kidney disease

  • liver disease

  • an unusual or allergic reaction to capecitabine, 5-fluorouracil, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water, within 30 minutes of the end of a meal. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose. It is very important that you know how to correctly take your dose. Taking the wrong tablets could result in an overdose (too much medication) or underdose (too little medication).

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, do not take the missed dose at all. Do not take double or extra doses. Instead, continue with your next scheduled dose and check with your doctor.

What may interact with this medicine?

  • antacids with aluminum and/or magnesium

  • folic acid

  • leucovorin

  • medicines to increase blood counts like filgrastim, pegfilgrastim, sargramostim

  • phenytoin

  • vaccines

  • warfarin

Talk to your doctor or health care professional before taking any of these medicines:

  • acetaminophen

  • aspirin

  • ibuprofen

  • ketoprofen

  • naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for checks on your progress. This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

Men are advised not to father a child while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

  • signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

  • signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

  • signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

  • breathing problems

  • changes in vision

  • chest pain

  • diarrhea of more than 4 bowel movements in one day or any diarrhea at night

  • mouth sores

  • nausea and vomiting

  • pain, swelling, redness at site where injected

  • pain, tingling, numbness in the hands or feet

  • redness, swelling, or sores on hands or feet

  • stomach pain

  • vomiting

  • yellow color of skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation

  • diarrhea

  • dry or itchy skin

  • hair loss

  • loss of appetite

  • nausea

  • weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.


Broward Health Medical Center Clinical Trials Program focuses on having available clinical trials to improve cancer care by finding better ways to treat cancer and help cancer patients.

The decision to enroll in a clinical trial is voluntary and one that should be made with the close consultation of a physician.

For further information, please contact the Cancer Research Department:

Medical Hematologist / Oncologists
Radiation Oncologists
Research Nurses & Research Associates

Rowena Dimayuga, RN MSN CCRP
Melissa Hoag, Clinical Research Associate
Donna Stefinsky, RN CCRC 

Clinical Trials List

Updated: March 11, 2014

Breast

ECOG 3108: A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen
Principal Investigator: Archana Maini, MD
Status: Temporarily closed to accrual

ECOG 2108: A Randomized Phase III Trial of Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Principal Investigator: Barry Berman, MD
Status: Actively Recruiting

NSABP-B47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer
Principal Investigator: Barry Berman, MD
Status: Actively Recruiting

Agendia PROMIS Study: PROMIS: PRospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (18-30 Oncotype DX)
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

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Gastroesophageal

SWOG 1201: A Randomized Ph II Pilot Study Prospectively Evaluating Tx  for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/ Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer.
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

Head & Neck

RTOG 1016: Phase III Trial of Radiotherapy plus Cetuximab versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Principal Investigator: Marshal Lieberfarb, MD
Status: Actively Recruiting

SOLIGENIX: Phase II Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Multicenter Study of SGX942 for the Attenuation of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of H&N SCC
Principal Investigator: Archana Maini, MD
Status: COMING SOON

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Lung

ECOG 5508: Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced NSCLC
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

Amgen Protocol 20070782: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 μg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

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Multiple Myeloma

CELGENE 007: Phase III, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dex vs. Bortezomib and Low-Dose Dex in Subjects with Relapsed or Refractory Multiple Myeloma (MM)
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

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Prostate

RTOG 0815: A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy with/without Short-term Androgen Deprivation Therapy for Patients with Intermediate-Risk Prostate Cancer
Principal Investigator: Evan Landau, MD
Status: Actively Recruiting

SWOG 1216: A Phase III Randomized Trial Comparing Androgen deprivation therapy + TAK-700 with Androgen deprivation therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

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Other

BHMC 001: A Prospectively Acquired Database of Head and Neck Cancer Patients Receiving Radiation Therapy
Principal Investigator: Evan Landau, MD
Status:
Actively Recruiting

Please call the Principal Investigator or Study coordinator with any questions or potential subjects.

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