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

Pharmacokinetic Study of Adjuvant Capecitabine After Resection of Pancreatic Adenocarcinoma

Phase 4

Completed

Conditions: Pancreatic Adenocarcinoma

First Posted Date: 2009-03-03

Last Posted Date: 2013-02-18

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Target Recruit Count: 13

Registration Number: NCT00854477

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

Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers

Phase 2

Terminated

Conditions: Gastric Cancer
Esophageal Cancer
Gastric Adenocarcinoma

Interventions: Drug: Irinotecan
Drug: Cisplatin
Procedure: Surgery
Drug: Floxuridine
Drug: Capecitabine

First Posted Date: 2009-02-20

Last Posted Date: 2018-01-08

Lead Sponsor: NYU Langone Health

Target Recruit Count: 8

Registration Number: NCT00848783

Locations: 🇺🇸
Bellevue Hospital, New York, New York, United States
🇺🇸
NYU Cancer Center, New York, New York, United States
🇺🇸
Norris Cancer Center, Los Angeles, California, United States

Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

Phase 1

Completed

Conditions: Advanced Gastric Cancer
Stomach Neoplasms

Interventions: Drug: axitinib
Drug: capecitabine
Drug: cisplatin

First Posted Date: 2009-02-12

Last Posted Date: 2013-11-27

Lead Sponsor: Pfizer

Target Recruit Count: 22

Registration Number: NCT00842244

Locations: 🇰🇷
Pfizer Investigational Site, Seoul, Korea, Republic of

Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer

Phase 2

Completed

Conditions: Advanced Gastric Cancer

Interventions: Drug: endostar, cisplatin, capecitabine
Drug: capecitabine
Drug: cisplatin

First Posted Date: 2009-02-12

Last Posted Date: 2015-05-19

Lead Sponsor: Peking University

Target Recruit Count: 45

Registration Number: NCT00842491

Locations: 🇨🇳
Department of GI Oncology, Peking University, School of Oncology, Beijing, Beijing, China

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Trastuzumab emtansine
Drug: Lapatinib
Drug: Capecitabine

First Posted Date: 2009-01-26

Last Posted Date: 2016-10-31

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 991

Registration Number: NCT00829166

Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer

Phase 2

Completed

Conditions: Locally Advanced Rectal Cancer

Interventions: Drug: Oxaliplatin
Drug: Bevacizumab
Drug: Capecitabine
Radiation: radiotherapy

First Posted Date: 2009-01-26

Last Posted Date: 2019-07-10

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 84

Registration Number: NCT00828672

Locations: 🇧🇪
H. Hartziekenhuis, Roeselare, Belgium
🇧🇪
Erasme Hospital, Brussels, Belgium
🇧🇪
Clinique Sainte Elisabeth, Namur, Belgium

and more 6 locations

TaxXel: Taxotere and Xeloda in Esophageal Cancer

Phase 1

Conditions: Cancer of the Esophagus
Gastric Cardia Carcinoma

Interventions: Drug: Docetaxel
Drug: Capecitabine

First Posted Date: 2009-01-14

Last Posted Date: 2012-02-28

Lead Sponsor: Karolinska University Hospital

Target Recruit Count: 93

Registration Number: NCT00821912

Locations: 🇳🇴
Haukeland universitetssykehus, Bergen, Norway
🇸🇪
Malmö General University Hospital, Malmö, Sweden
🇸🇪
Västerås Central Hospital, Västerås, Sweden

and more 7 locations

Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

Phase 3

Completed

Conditions: Metastases, Brain

Interventions: Drug: capecitabine
Drug: lapatinib
Drug: trastuzumab

First Posted Date: 2009-01-12

Last Posted Date: 2019-04-02

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 540

Registration Number: NCT00820222

Locations: 🇬🇧
Novartis Investigative Site, Worthing, United Kingdom

Capecitabine and Radiation Therapy With or Without Panitumumab in Treating Patients With Advanced Rectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: panitumumab
Drug: capecitabine
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy

First Posted Date: 2008-12-25

Last Posted Date: 2014-04-30

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 68

Registration Number: NCT00814619

Locations: 🇨🇭
Hirslanden Klinik Aarau, Aarau, Switzerland
🇨🇭
City Hospital Triemli, Zurich, Switzerland
🇨🇭
UniversitaetsSpital Zuerich, Zurich, Switzerland

and more 21 locations

Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years)

Phase 4

Completed

Conditions: Colorectal Cancer
Breast Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2008-12-22

Last Posted Date: 2018-08-28

Lead Sponsor: University Hospital, Limoges

Target Recruit Count: 20

Registration Number: NCT00812864

Locations: 🇫🇷
CHU Limoges, Limoges Cedex, Province, France

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