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

A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

Phase 1

Completed

Conditions: Stomach Neoplasms
Esophageal Neoplasms

Interventions: Drug: BMS-833923
Drug: Cisplatin
Drug: Capecitabine

First Posted Date: 2009-05-28

Last Posted Date: 2013-06-21

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 39

Registration Number: NCT00909402

Locations: 🇳🇱
Local Institution, Amsterdam, Netherlands
🇺🇸
City Of Hope National Medical Center, Duarte, California, United States
🇺🇸
Usc/Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 1 locations

Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction

Phase 2

Completed

Conditions: Esophageal Cancer
Adenocarcinoma of the Gastroesophageal Junction

Interventions: Drug: capecitabine
Drug: sunitinib malate

First Posted Date: 2009-05-01

Last Posted Date: 2018-07-24

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 12

Registration Number: NCT00891878

Locations: 🇺🇸
Memorial Hospital, Carthage, Illinois, United States
🇺🇸
Graham Hospital, Canton, Illinois, United States
🇺🇸
Illinois CancerCare - Havana, Havana, Illinois, United States

and more 178 locations

Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

Phase 1

Terminated

Conditions: Pancreatic Cancer

Interventions: Radiation: Neoadjuvant Short-Course Photon Radiation
Drug: Capecitabine

First Posted Date: 2009-04-28

Last Posted Date: 2018-05-11

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 10

Registration Number: NCT00889187

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer

Phase 3

Completed

Conditions: Gastric Cancer

Interventions: Drug: Placebo
Drug: Bevacizumab
Drug: Capecitabine
Drug: Cisplatin

First Posted Date: 2009-04-24

Last Posted Date: 2017-03-01

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 202

Registration Number: NCT00887822

Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer

Phase 1

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: capecitabine
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride

First Posted Date: 2009-04-21

Last Posted Date: 2015-02-10

Lead Sponsor: Centre Antoine Lacassagne

Target Recruit Count: 30

Registration Number: NCT00885066

Locations: 🇫🇷
Centre Antoine Lacassagne, Nice, France

A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Gemcitabine
Drug: Docetaxel
Drug: Capecitabine

First Posted Date: 2009-04-16

Last Posted Date: 2016-07-25

Lead Sponsor: Columbia University

Target Recruit Count: 37

Registration Number: NCT00882310

Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma

Phase 4

Terminated

Conditions: Adenocarcinoma of the Stomach

First Posted Date: 2009-03-30

Last Posted Date: 2015-07-21

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Target Recruit Count: 13

Registration Number: NCT00871273

Locations: 🇬🇧
Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre, Cambridge, United Kingdom
🇬🇧
Edinburgh Cancer Centre, Western General Hospital, Edinburgh, United Kingdom

External-Beam Radiation Therapy, Capecitabine, and Sorafenib in Treating Patients With Locally Advanced Rectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

Interventions: Drug: capecitabine
Drug: sorafenib tosylate
Radiation: radiation therapy

First Posted Date: 2009-03-26

Last Posted Date: 2019-05-15

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 54

Registration Number: NCT00869570

Locations: 🇨🇭
Kantonsspital Winterthur, Winterthur, Switzerland
🇨🇭
Kantonsspital Graubuenden, Chur, Switzerland
🇨🇭
Kantonsspital - St. Gallen, St. Gallen, Switzerland

and more 15 locations