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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

Bevacizumab, Erlotinib and Capecitabine for Advanced Pancreatic Cancer

Phase 1
Completed
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2008-02-13
Last Posted Date
2016-08-01
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
17
Registration Number
NCT00614653
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Interventions
Drug: capecitabine
Drug: oxaliplatin
Procedure: resection
Radiation: radiation therapy
Drug: FOLFOX
First Posted Date
2008-02-12
Last Posted Date
2018-09-25
Lead Sponsor
Radiation Therapy Oncology Group
Target Recruit Count
79
Registration Number
NCT00613080
Locations
🇺🇸

Piedmont Hospital, Atlanta, Georgia, United States

🇺🇸

Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States

🇺🇸

Auburn Radiation Oncology, Auburn, California, United States

and more 117 locations

Perioperative Therapy for Resectable Pancreatic Cancer

Phase 2
Completed
Conditions
Adenocarcinoma of the Pancreas
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Interventions
Drug: gemcitabine hydrochloride
Drug: docetaxel
Drug: capecitabine
Radiation: intensity-modulated radiation therapy
Drug: oxaliplatin
Procedure: pancreatic surgical procedure
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
First Posted Date
2008-02-07
Last Posted Date
2017-07-13
Lead Sponsor
University of Washington
Target Recruit Count
35
Registration Number
NCT00609336
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

Phase 1
Completed
Conditions
Metastatic Liver Cancer
Interventions
Radiation: SIRT
Drug: capecitabine
First Posted Date
2008-01-30
Last Posted Date
2015-09-07
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
34
Registration Number
NCT00604409
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery

Phase 2
Completed
Conditions
Pancreatic Cancer
Interventions
Biological: panitumumab
Drug: capecitabine
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
First Posted Date
2008-01-28
Last Posted Date
2017-04-05
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
52
Registration Number
NCT00601627
Locations
🇺🇸

Great Falls Clinic - Main Facility, Great Falls, Montana, United States

🇺🇸

Mid Dakota Clinic, PC, Bismarck, North Dakota, United States

🇺🇸

Illinois CancerCare - Canton, Canton, Illinois, United States

and more 274 locations

Imatinib, Capecitabine, and Cisplatin in Treating Patients With Unresectable or Metastatic Stomach Cancer

Phase 1
Completed
Conditions
Gastric Cancer
Interventions
Drug: capecitabine
Drug: cisplatin
Drug: imatinib mesylate
First Posted Date
2008-01-28
Last Posted Date
2013-03-19
Lead Sponsor
Technical University of Munich
Target Recruit Count
38
Registration Number
NCT00601510
Locations
🇩🇪

Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich, Germany

Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors

Phase 2
Completed
Conditions
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
First Posted Date
2008-01-28
Last Posted Date
2013-08-07
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
84
Registration Number
NCT00602082
Locations
🇬🇧

Basildon University Hospital, Basildon, England, United Kingdom

🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

🇬🇧

Mid Kent Oncology Centre at Maidstone Hospital, Maidstone, England, United Kingdom

and more 14 locations

Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Phase 2
Completed
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2008-01-03
Last Posted Date
2017-04-10
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
40
Registration Number
NCT00585078
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma

Phase 2
Completed
Conditions
Gastrointestinal Cancer
Interventions
Drug: AMG 386 3mg/kg
Drug: AMG 386 placebo
Drug: AMG 386 10mg/kg
Drug: Cisplatin
Drug: Capecitabine
First Posted Date
2007-12-31
Last Posted Date
2014-05-07
Lead Sponsor
Amgen
Target Recruit Count
171
Registration Number
NCT00583674

Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer

Phase 1
Completed
Conditions
Cancer of the Esophagus
Interventions
First Posted Date
2007-12-20
Last Posted Date
2015-07-02
Lead Sponsor
Brian Czito
Target Recruit Count
29
Registration Number
NCT00578071
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

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