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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

Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

Phase 3
Completed
Conditions
Colorectal Cancer
Interventions
First Posted Date
2012-10-31
Last Posted Date
2023-04-12
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
230
Registration Number
NCT01718873
Locations
🇮🇹

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy

Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal Cancer

Phase 1
Conditions
Rectal Cancer
Interventions
Radiation: Radiotherapy
Procedure: Hyperthermia
Drug: 5-Fluorouracil
Drug: Capecitabine
Drug: Oxaliplatin
First Posted Date
2012-10-30
Last Posted Date
2017-08-11
Lead Sponsor
University of Erlangen-Nürnberg Medical School
Target Recruit Count
59
Registration Number
NCT01716949
Locations
🇩🇪

LMU München, Campus Großhadern, Medizinische Klinik III, Hyperthermie, München, Germany

🇩🇪

Klinik Bad Trissl, Innere Medizin, Bad Trissl, Germany

🇩🇪

Schlossbergklinik, Oberstaufen, Germany

and more 3 locations

Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma

Phase 2
Completed
Conditions
Gastric Cancer
Interventions
First Posted Date
2012-10-22
Last Posted Date
2022-05-05
Lead Sponsor
xie congying
Target Recruit Count
208
Registration Number
NCT01711242
Locations
🇨🇳

The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, China

A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer

Phase 2
Completed
Conditions
Gastro Oesophageal Cancer
Interventions
First Posted Date
2012-10-19
Last Posted Date
2013-01-10
Lead Sponsor
Cancer Trials Ireland
Target Recruit Count
35
Registration Number
NCT01710592
Locations
🇮🇪

Mercy University Hospital, Cork, Ireland

🇮🇪

Beaumont Hospital, Dublin, Ireland

🇮🇪

Mater Misericordiae University hospital & Mater Private Hospital, Dublin, Ireland

and more 3 locations

Intravenously Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PROMITIL) in Cancer Patients With Solid Tumors.

Phase 1
Completed
Conditions
Metastatic Colorectal Cancer (mCRC)
Cancer
Solid Tumor
Interventions
First Posted Date
2012-10-12
Last Posted Date
2018-07-10
Lead Sponsor
Lipomedix Pharmaceuticals Inc.
Target Recruit Count
88
Registration Number
NCT01705002
Locations
🇮🇱

Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel

🇮🇱

Chaim Sheba Medical center, Ramat Gan, Israel

🇮🇱

Rambam Health Care Campus, Haifa, Israel

and more 1 locations

Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies

Phase 1
Terminated
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug: capecitabine
Drug: celecoxib
Other: pharmacological study
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
First Posted Date
2012-10-12
Last Posted Date
2018-05-30
Lead Sponsor
University of Chicago
Target Recruit Count
21
Registration Number
NCT01705106
Locations
🇺🇸

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)

Phase 2
Terminated
Conditions
Breast Cancer
Gastric Cancer
Interventions
First Posted Date
2012-10-08
Last Posted Date
2021-01-22
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
182
Registration Number
NCT01702558
Locations
🇧🇷

Hospital Erasto Gaertner, Curitiba, PR, Brazil

🇧🇷

Instituto Oncologico de Ribeirao Preto - INORP, Ribeirao Preto, SP, Brazil

🇧🇷

Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*, Sao Jose do Rio Preto, SP, Brazil

and more 37 locations

First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma

Phase 3
Terminated
Conditions
Gastric Cancer
Interventions
First Posted Date
2012-10-02
Last Posted Date
2016-02-09
Lead Sponsor
Amgen
Target Recruit Count
609
Registration Number
NCT01697072
Locations
🇬🇧

Research Site, Sutton, United Kingdom

An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer

Completed
Conditions
Colorectal Cancer
Interventions
Drug: Capecitabine
Drug: Chemotherapy
First Posted Date
2012-10-01
Last Posted Date
2017-03-23
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
882
Registration Number
NCT01696695
Locations
🇭🇺

Josa Andras Korhaz; Dept of Oncoradiology, Nyíregyháza, Hungary

🇭🇺

Zala megyei Önkormányzat Kórház és Rendelõintézet, Zalaegerszeg, Hungary

🇭🇺

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika, Budapest, Hungary

and more 19 locations

Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy

Phase 2
Completed
Conditions
Colorectal Neoplasms
Interventions
First Posted Date
2012-09-03
Last Posted Date
2016-06-09
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
10
Registration Number
NCT01677884
Locations
🇫🇷

Institut Gustave Roussy, Villejuif, Val de Marne, France

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