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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

Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2013-07-03
Last Posted Date
2018-11-07
Lead Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Target Recruit Count
40
Registration Number
NCT01891227
Locations
🇦🇹

KH Barmh. Schwestern Linz, Innere Medizin I Hämatologie/Onkologie, Linz, Austria

🇦🇹

Universitätsklinik f. Frauenheilkunde und Geburtshilfe, Klin. Abt. f. Gynäkologie, Graz, Austria

🇦🇹

Hämatologie und Onkologie/Interne E, LKH Feldkirch, Feldkirch, Austria

and more 5 locations

Capecitabine With Digoxin for Metastatic Breast Cancer

Phase 2
Terminated
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2013-06-26
Last Posted Date
2018-02-22
Lead Sponsor
Western Regional Medical Center
Target Recruit Count
16
Registration Number
NCT01887288
Locations
🇺🇸

Western Regional Medical Center, Goodyear, Arizona, United States

Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer

Phase 2
Conditions
Colorectal Neoplasms
Interventions
First Posted Date
2013-06-19
Last Posted Date
2014-02-11
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
100
Registration Number
NCT01880658
Locations
🇨🇳

Gastrointestinal Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer

Phase 2
Terminated
Conditions
HER2-positive Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions
Drug: capecitabine
Drug: cyclophosphamide
Drug: lapatinib ditosylate
Biological: trastuzumab
Other: laboratory biomarker analysis
First Posted Date
2013-06-10
Last Posted Date
2023-10-05
Lead Sponsor
University of Southern California
Target Recruit Count
10
Registration Number
NCT01873833
Locations
🇺🇸

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

Phase II Trial for Large ER-Negative Breast Cancers

Phase 2
Completed
Conditions
Malignant Neoplasm of Female Breast
Interventions
First Posted Date
2013-06-05
Last Posted Date
2019-09-24
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
72
Registration Number
NCT01869192
Locations
🇺🇸

University of Colorado Cancer Center, Aurora, Colorado, United States

Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine

Phase 2
Completed
Conditions
Cancer of Unknown Primary Site
Bile Duct Neoplasms
Gastrointestinal Cancer
Pancreatic Cancer
Interventions
First Posted Date
2013-05-03
Last Posted Date
2023-05-12
Lead Sponsor
University of Edinburgh
Target Recruit Count
59
Registration Number
NCT01845337
Locations
🇬🇧

Edinburgh Cancer Centre, Edinburgh, Scotland, United Kingdom

A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer

Phase 2
Conditions
Oesophageal Cancer
Interventions
First Posted Date
2013-05-01
Last Posted Date
2014-03-24
Lead Sponsor
Lisette Nixon
Target Recruit Count
85
Registration Number
NCT01843829
Locations
🇬🇧

University Hospitals Coventry and Warwickshire, Coventry, United Kingdom

🇬🇧

Bristol Oncology and Haematology Centre, Bristol, United Kingdom

🇬🇧

Valindre NHS, Cardiff, United Kingdom

and more 9 locations

Phase 1 Study Testing the Combination of Aflibercept and Capecitabine in Metastatic Digestive and Breast Cancers

Phase 1
Completed
Conditions
Metastatic Gastric Cancers
Metastatic Colorectal Cancers
Metastatic Oesophageal Cancers
Metastatic Pancreatic Cancers
Metastatic Biliary Cancers
Metastatic Breast Cancers
Interventions
First Posted Date
2013-05-01
Last Posted Date
2018-01-31
Lead Sponsor
Jules Bordet Institute
Target Recruit Count
37
Registration Number
NCT01843725
Locations
🇧🇪

Institut Jules Bordet, Brussels, Belgium

Phase II Study of Concomitant Intensity-modulated Radiotherapy Combined to Capecitabine, Mitomycin and Panitumumab in Patients With Stage II-IIIB Squamous-cell Carcinoma of the Anal Canal

Phase 2
Terminated
Conditions
Carcinoma of Anal Canal
Interventions
Radiation: RADIOTHERAPY
Biological: PANITUMUMAB
Drug: MITOMYCIN
Drug: CAPECITABINE
First Posted Date
2013-04-30
Last Posted Date
2016-05-19
Lead Sponsor
Centre Hospitalier Universitaire Vaudois
Target Recruit Count
8
Registration Number
NCT01843452
Locations
🇨🇭

Inselspital, Bern, Switzerland

🇨🇭

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

🇨🇭

Hôpitaux Universitaires de Genève (HUG), Geneva, Switzerland

and more 1 locations

Immunotherapy Study in Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

Phase 3
Terminated
Conditions
Pancreatic Carcinoma Non-resectable
Locally Advanced Malignant Neoplasm
Pancreatic Cancer
Interventions
Drug: FOLFIRINOX
Radiation: 5-FU Chemoradiation
Biological: Algenpantucel-L Immunotherapy
Drug: Gemcitabine
Drug: Capecitabine
Drug: Nab-Paclitaxel
First Posted Date
2013-04-19
Last Posted Date
2020-05-28
Lead Sponsor
NewLink Genetics Corporation
Target Recruit Count
302
Registration Number
NCT01836432
Locations
🇺🇸

Sutter Institute for Medical Research, Sacramento, California, United States

🇺🇸

USF Tampa General, Tampa, Florida, United States

🇺🇸

Indiana University Health Goshen Center for Cancer Care, Goshen, Indiana, United States

and more 29 locations
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