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

Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

Phase 3

Completed

Conditions: Nasopharyngeal Carcinoma

Interventions: Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )
Drug: Induction chemotherapy using PF (5-Fluorouracil)
Drug: Capecitabine

First Posted Date: 2006-09-21

Last Posted Date: 2019-08-07

Lead Sponsor: Hong Kong Nasopharyngeal Cancer Study Group Limited

Target Recruit Count: 803

Registration Number: NCT00379262

Locations: 🇨🇳
Cancer Center, Sun Yat Sen University, Guangzhou, China
🇨🇳
Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, China
🇨🇳
Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong, China

and more 4 locations

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Phase 3

Terminated

Conditions: Breast Neoplasms

Interventions: Drug: Capecitabine
Drug: Sunitinib malate

First Posted Date: 2006-09-07

Last Posted Date: 2012-06-25

Lead Sponsor: Pfizer

Target Recruit Count: 482

Registration Number: NCT00373113

Locations: 🇬🇧
Pfizer Investigational Site, Somerset, United Kingdom

AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: capecitabine
Drug: AZD6244

First Posted Date: 2006-09-07

Last Posted Date: 2014-08-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 70

Registration Number: NCT00372944

Locations: 🇷🇴
Research Site, Cluj-Napoca, Romania

Therapy With Bevacizumab (BEV), Doxorubicin, and Cyclophosphamide Followed by BEV, Docetaxel, and Capecitabine Before Surgery Followed by BEV Alone After Surgery for Women With Locally Advanced Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Bevacizumab
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Capecitabine
Drug: Docetaxel

First Posted Date: 2006-08-17

Last Posted Date: 2021-04-13

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 45

Registration Number: NCT00365417

Locations: 🇺🇸
NSABP Foundation, Inc., Pittsburgh, Pennsylvania, United States

Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer

Phase 3

Completed

Conditions: Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer

First Posted Date: 2006-08-15

Last Posted Date: 2013-08-26

Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Target Recruit Count: 360

Registration Number: NCT00363584

Locations: 🇬🇧
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom
🇬🇧
St. Thomas' Hospital, London, England, United Kingdom
🇬🇧
Royal Bournemouth Hospital, Bournemouth, England, United Kingdom

and more 43 locations

Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2006-07-27

Last Posted Date: 2013-01-10

Lead Sponsor: Pediatric Brain Tumor Consortium

Target Recruit Count: 24

Registration Number: NCT00357253

Locations: 🇺🇸
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
🇺🇸
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

and more 9 locations