Capecitabine

Generic Name: Capecitabine

Brand Names: Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₂₂FN_₃O_₆

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

Clinical Trials

Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Gemcitabine
Drug: Capecitabine
Drug: Vinorelbine

First Posted Date: 2007-02-05

Last Posted Date: 2009-09-28

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 144

Registration Number: NCT00431106

Locations: 🇬🇷
401 Military Hospital of Athens, Athens, Greece
🇬🇷
University General Hospital of Alexandroupolis, Dept. of Medical Oncology, Alexandroupolis, Greece
🇬🇷
"IASO" General Hospital of Athens, 1st Dept. of Medical Oncology, Athens, Greece

and more 7 locations

Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

Not Applicable

Terminated

Conditions: Esophageal Adenocarcinoma

Interventions: Drug: Capecitabine
Drug: Oxaliplatin
Drug: Cetuximab

First Posted Date: 2007-02-01

Last Posted Date: 2013-12-12

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 8

Registration Number: NCT00430027

Locations: 🇺🇸
University of Colorado at Denver and Health Science Center, Aurora, Colorado, United States

Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Docetaxel
Drug: Capecitabine
Drug: Epirubicin

First Posted Date: 2007-02-01

Last Posted Date: 2009-05-29

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 272

Registration Number: NCT00429871

Locations: 🇬🇷
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece
🇬🇷
Air Forces Military Hospital of Athens, Athens, Greece
🇬🇷
401 Military Hospital of Athens, Athens, Greece

and more 7 locations

Capecitabine and Oxaliplatin or Standard Follow-Up Care in Treating Patients Who Have Undergone Surgery for Locally Advanced Rectal Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

First Posted Date: 2007-01-29

Last Posted Date: 2013-08-26

Lead Sponsor: Cancer Research UK

Target Recruit Count: 800

Registration Number: NCT00427713

Locations: 🇬🇧
Wansbeck General Hospital, Ashington, England, United Kingdom
🇬🇧
Good Hope Hospital, Birmingham, England, United Kingdom
🇬🇧
Furness General Hospital, Barrow in Furness, England, United Kingdom

and more 69 locations

Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Phase 3

Completed

Conditions: Pancreatic Cancer

First Posted Date: 2007-01-23

Last Posted Date: 2013-08-26

Lead Sponsor: Royal Liverpool University Hospital

Target Recruit Count: 1110

Registration Number: NCT00425360

Locations: 🇬🇧
Pilgrim Hospital, Boston, England, United Kingdom
🇬🇧
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
🇬🇧
Dorset County Hospital, Dorchester, England, United Kingdom

and more 42 locations

Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Drug: fluorouracil
Drug: capecitabine
Drug: irinotecan hydrochloride
Drug: leucovorin calcium

First Posted Date: 2007-01-18

Last Posted Date: 2021-02-17

Lead Sponsor: UNICANCER

Target Recruit Count: 145

Registration Number: NCT00423696

Locations: 🇫🇷
C.H.U. de Brest, Brest, France
🇫🇷
Centre Regional Francois Baclesse, Caen, France
🇫🇷
Centre Oscar Lambret, Lille, France

and more 12 locations

Standard Versus Continuous Capecitabine in Advanced Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2007-01-04

Last Posted Date: 2019-02-22

Lead Sponsor: Hospital San Carlos, Madrid

Target Recruit Count: 195

Registration Number: NCT00418028

Locations: 🇪🇸
Hospital Clinico San Carlos, Madrid, Spain

Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen

Phase 3

Completed

Conditions: Pancreatic Neoplasms

Interventions: Drug: Larotaxel (XRP9881)
Drug: 5-Fluorouracil
Drug: Capecitabine

First Posted Date: 2006-12-29

Last Posted Date: 2016-06-03

Lead Sponsor: Sanofi

Target Recruit Count: 408

Registration Number: NCT00417209

Locations: 🇬🇧
Sanofi-Aventis Administrative Office, Guildford, Surrey, United Kingdom

Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Drug: oxaliplatin
Drug: Capecitabine

First Posted Date: 2006-12-28

Last Posted Date: 2014-09-03

Lead Sponsor: Herbert Hurwitz, MD

Target Recruit Count: 50

Registration Number: NCT00416494

Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer

Phase 2

Conditions: Breast Neoplasms

First Posted Date: 2006-12-22

Last Posted Date: 2007-02-13

Lead Sponsor: Georgia Center for Oncology Research & Education

Target Recruit Count: 100

Registration Number: NCT00415285

Locations: 🇺🇸
Emory Crawford Long Hospital, Atlanta, Georgia, United States
🇺🇸
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
🇺🇸
Grady Memorial Hospital, Atlanta, Georgia, United States

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