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

Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer

First Posted Date
2005-09-22
Last Posted Date
2018-11-02
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
72
Registration Number
NCT00215644
Locations
🇬🇧

Research Site, Portsmouth, United Kingdom

Patients Preference for Oral or i.v. Therapy

Phase 3
Completed
Conditions
First Posted Date
2005-09-21
Last Posted Date
2005-09-21
Lead Sponsor
Odense University Hospital
Target Recruit Count
60
Registration Number
NCT00212589
Locations
🇩🇰

Department of Oncology, Esbjerg Hospital, Esbjerg, Denmark

🇩🇰

Department of Oncology, Odense University Hospital, Odense, Denmark

🇩🇰

Department of Oncology, Sonderborg Hospital, Sonderborg, Denmark

and more 1 locations

Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-09-21
Last Posted Date
2015-03-27
Lead Sponsor
Emory University
Target Recruit Count
51
Registration Number
NCT00209092
Locations
🇺🇸

Grady Memorial Hospital, Atlanta, Georgia, United States

🇺🇸

Augusta Oncology Associates, PC 3696 Wheeler Road, Augusta, Georgia, United States

🇺🇸

Emory Crawford Long Hospital, Atlanta, Georgia, United States

and more 8 locations

Effect of Capecitabine on the Pharmacokinetics of BMS-247550 and BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

First Posted Date
2005-09-21
Last Posted Date
2017-01-30
Lead Sponsor
R-Pharm
Target Recruit Count
25
Registration Number
NCT00207129
Locations
🇺🇸

Local Institution, San Antonio, Texas, United States

Mono Efficacy of Capecitabine (MoniCa)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-09-20
Last Posted Date
2011-10-06
Lead Sponsor
German Breast Group
Target Recruit Count
200
Registration Number
NCT00196820
Locations
🇩🇪

J. W. Goethe Universität, Frauenklinik, Frankfurt am Main, Hessen, Germany

Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary

First Posted Date
2005-09-20
Last Posted Date
2016-09-23
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Target Recruit Count
57
Registration Number
NCT00201734
Locations
🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

First Posted Date
2005-09-20
Last Posted Date
2014-10-06
Lead Sponsor
Tony Bekaii-Saab
Target Recruit Count
29
Registration Number
NCT00201825
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Phase 2
Terminated
Conditions
First Posted Date
2005-09-19
Last Posted Date
2011-05-03
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
40
Registration Number
NCT00193102

Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site

First Posted Date
2005-09-19
Last Posted Date
2013-11-11
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
48
Registration Number
NCT00193609
Locations
🇺🇸

Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States

🇺🇸

Greenview Regional Hospital, Bowling Green, Kentucky, United States

🇺🇸

Baton Rouge General Medical Center, Baton Rouge, Louisiana, United States

and more 7 locations

Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

Phase 3
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2007-05-28
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
300
Registration Number
NCT00191438
Locations
🇬🇧

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nottingham City, Nottinghamshire, United Kingdom

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