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: July 21, 2014

Brain

RTOG 1122: Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab with or without AMG386 in Patients with Recurrent Glioblastoma or Gliosarcoma
Principal Investigator: Delia Constanza Guaqueta, MD
Status: Actively Recruiting

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Breast

AGENDIA PROMIS: Prospective Study of MammaPrint in Breast Cancer Patients with an Intermediate Recurrence Score (PROMIS)
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

AMGEN 20060359: A Randomized, Double-Blind, Placebo Controlled, Multicenter Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early Stage Breast Cancer at High Risk of Recurrence (D-CARE)
Principal Investigator: Archana Maini, MD

ACOSOG Z1041: A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel plus Trastuzumab with a Neoadjuvant Regimen of Paclitaxel plus Trastuzumab followed by FEC-75 plus Trastuzumab in Patients with Palpable and Operable Breast Cancer
Principal Investigator: Archana Maini, MD

ECOG E2108: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Principal Investigator: Barry Berman, MD
Status: Actively Recruiting

ECOG-PACCT1: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
Principal Investigator: Archana Maini, MD

ECOG 5103: A Double-Blind Phase III Trial of AC followed by Paclitaxel with Avastin or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
Principal Investigator: Archana Maini, MD

CALGB 49802: Phase III Study of Adriamycin / Taxotere vs. Adriamycin / Cytoxan in the Adjuvant Treatment of Node Positive and High Risk Node Negative Breast Cancer
Principal Investigator: Luis Barreras, MD

CALGB 9741: A Randomized Phase III Trial of Sequential Chemotherapy using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 to 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer
Principal Investigator: Luis Barreras, MD

NCCTG N9831: Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel with or without Trastuzumab as Adjuvant Treatment for Women with Her-2 Over-expressing or Amplified Node Positive or High Risk Node Negative Breast Cancer
Principal Investigator: Archana Maini, MD

NSABP B-35: A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy
Principal Investigator: Archana Maini, MD

NSABP B-36: A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients with Node-Negative Breast Cancer
Principal Investigator: Archana Maini, MD

NSABP B-38: A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women with Node-positive Breast Cancer: Docetaxel / Doxirubicin / Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC -> P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC-> PG)
Principal Investigator: Archana Maini, MD

NSABP B-40: A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens
Principal Investigator: Archana Maini, MD

PFIZER B3271002: A Phase 3 Randomized, Double-Blind Study of PF-05280014 plus Paclitaxel versus Trastuzumab plus Paclitaxel for the First Line Treatment of Patients with HER2-Postive Metastatic Breast Cancer
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

SWOG S0307: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Principal Investigator: Archana Maini, MD

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Colon

ECOG 5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin, and Oxaliplatin vs. 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence
Principal Investigator: Archana Maini, MD

NCCTG N0147: A Randomized Phase III Trial of Oxaliplatin (OXAL) plus 5-Flurouracil (5-FU) / Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer
Principal Investigator: Archana Maini, MD

Dermatology

E2603: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma
Principal Investigator: Archana Maini, MD

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Gastroesophageal

S1201: A Randomized Phase II Pilot Study Prospectively Evaluating Treatment 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

Gynecologic

GOG 262: A Phase III Trial Of Every-3-Weeks Paclitaxel versus Dose Dense Weekly Paclitaxel in Combination with Carboplatin with or without Concurrent and Consolidation Bevacizumab (NSC #704865, IND #113912) in the Treatment of Primary Stage II, III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging to Evaluate Treatment Response in Patients Participating in GOG-0262
Principal Investigator: Archana Maini, MD

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 IDR-OM-01: A Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating, Multicenter Study of SGX942 for the Attenuation of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation (CRT) for the Treatment of Squamous Cell Carcinoma of the Head and Neck
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

E3303: Phase II Study of C225 (Erbitux or Cetuximab) in Combination with Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck
Principal Investigator: Nicholas Tranakas, MD

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Hodgkin's Disease

CALGB 59905: A Randomized Phase III Trial of ABVD versus Stanford V ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin’s disease
Principal Investigator: Luis Barreras, MD

Lung

AMGEN 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

ECOG 1505: A Phase III Randomized Trial of Adjuvant Chemotherapy +/- Bevacizumab for Patients with Completely Resected Stage IB (>4cm) -IIIA NSCLC
Principal Investigator: Archana Maini, MD

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

RTOG 0617: A Randomized, Phase III Comparison of Standard Dose (60Gy) versus High Dose (74Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin / Paclitaxel +/- Cetuximab (IND #103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer
Principal Investigator: Marshal Lieberfarb, MD

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Multiple Myeloma

CELGENE CC-4047-MM-007: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide (POM), Bortezomib (BTZ) and Low-Dose Dexamethasone (LD-DEX) versus Bortezomib and Low-Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma (MM)
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

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Prostate

S1216: 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

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

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Renal

ECOG 2805: Randomized, Double-Blind, Phase III Trial of Adjuvant Sunitinib vs. Sorafenib vs. Placebo in Patients with Resected Renal Cell Carcinoma (RCC)
Principal Investigator: Archana Maini, MD

Other

CELGENE CONNECT MDS AND AML: Connect MDS and AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Principal Investigator: Archana Maini, MD
Status: Actively Recruiting

S0702: A Prospective, Observational, Multi-Center Cohort Study to Assess the Incidence of ONJ (Osteonecrosis of the Jaw) in Cancer Patients with Bone Metastases Starting Zoledronic Acid
Principal Investigator: Archana Maini, MD

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

CALGB 70604: A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
Principal Investigator: Archana Maini, MD


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

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