Capecitabine

Generic Name
Capecitabine
Brand Names
Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva
Drug Type
Small Molecule
Chemical Formula
C15H22FN3O6
CAS Number
154361-50-9
Unique Ingredient Identifier
6804DJ8Z9U
Background

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Indication

Capecitabine is indicated as treatment for a variety of cancer types. For colorectal cancer, capecitabine is indicated as a single agent or a component of a combination chemotherapy regiment for the adjuvant treatment of stage III colon cancer and treatment unresectable or metastatic colorectal cancer. It can also be used as a part of a combination chemotherapy perioperative treatment of adult locally advanced rectal cancer. For breast cancer, capecitabine is indicated for advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated or as a regimen with docetaxel after disease progression on prior anthracycline-containing chemotherapy. For gastric, esophageal, or gastroesophageal junction (GEJ) cancer, capecitabine is indicated as a component of a combination chemotherapy treatment for the treatment of adult unresectable or metastatic gastric, esophageal, or GEJ cancer or adult HER2-overexpressing metastatic gastric or GEJ adenocarcinoma who have not received prior treatment for metastatic disease. Finally, for pancreatic cancer, capecitabine is indicated as adjuvant treatment for adult pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Associated Conditions
Advanced or Metastatic Breast Cancer, Carcinoma of Gallbladder, Cholangiocarcinoma, Hepatocellular Carcinoma, Locally Advanced Rectal Cancer (LARC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Gastric Cancers, Metastatic Neuroendocrine Tumors, Pancreatic Adenocarcinoma, Pancreatic Cancer, Advanced or Metastatic, Platinum-resistant Epithelial Ovarian Cancer, Refractory Fallopian Tube Carcinoma, Stage III Colon Cancer, Unresectable or Metastatic Colorectal Cancer, Metastatic pancreatic endocrine carcinoma, Refractory peritoneal cancer, Refractory, metastatic Colorectal carcinoma, Unresectable, metastatic Esophageal Cancer, Unresectable, metastatic Gastric Cancer, Unresectable, metastatic Gastroesophageal Junction Cancer
Associated Therapies
Chemotherapy

Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

First Posted Date
2005-09-07
Last Posted Date
2015-03-24
Lead Sponsor
Craig A. Bunnell, MD, MPH
Target Recruit Count
55
Registration Number
NCT00146588
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Center, Boston, Massachusetts, United States

Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site

Phase 2
Terminated
Conditions
First Posted Date
2005-09-07
Last Posted Date
2008-01-10
Lead Sponsor
University of Michigan Rogel Cancer Center
Registration Number
NCT00148135
Locations
🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Docetaxel and Capecitabine in Advanced Gastric Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-09-02
Last Posted Date
2007-04-18
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
80
Registration Number
NCT00142038
Locations
🇩🇪

Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Dept. of Hematology and Oncology, Berlin, Germany

Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Patients With Biliary Tract and Gallbladder Cancer

First Posted Date
2005-09-02
Last Posted Date
2018-04-25
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
8
Registration Number
NCT00142480
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Study of Epirubicin (Pharmorubicin®), Carboplatin (Paraplatin®) and Capecitabine (Xeloda®) (ECC) in the Treatment of Unresectable Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer With Pharmacogenetic Correlates

Phase 1
Terminated
Conditions
First Posted Date
2005-08-17
Last Posted Date
2016-02-15
Lead Sponsor
AHS Cancer Control Alberta
Target Recruit Count
50
Registration Number
NCT00130936
Locations
🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab

First Posted Date
2005-08-15
Last Posted Date
2019-02-26
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
14
Registration Number
NCT00130507
Locations
🇪🇸

Spanish Breast Cancer Research Group (GEICAM), San Sebastián de los Reyes, Madrid, Spain

Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients

Phase 3
Completed
Conditions
Interventions
First Posted Date
2005-08-15
Last Posted Date
2023-03-31
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
876
Registration Number
NCT00130533
Locations
🇪🇸

Hospital General Universitario Morales Meseguer, Murcia, Spain

🇪🇸

Hospital Regional Universitario Carlos Haya, Málaga, Spain

🇪🇸

Hospital Universitario Virgen del Rocío, Sevilla, Spain

and more 45 locations

EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer

First Posted Date
2005-08-12
Last Posted Date
2023-03-31
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
1384
Registration Number
NCT00129935
Locations
🇪🇸

Hospital Arquitecto Marcide, Ferrol, A Coruña, Spain

🇪🇸

Hospital General Universitario de Elche, Elche, Alicante, Spain

🇪🇸

Hospital General Universitario de Elda, Elda, Alicante, Spain

and more 55 locations

Tarceva and Capecitabine for Pancreatic Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-07-29
Last Posted Date
2009-11-01
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
32
Registration Number
NCT00125021
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

First Posted Date
2005-07-28
Last Posted Date
2016-01-18
Lead Sponsor
Eisai Inc.
Target Recruit Count
135
Registration Number
NCT00124566
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