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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

Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

Phase 3
Terminated
Conditions
Cognitive/Functional Effects
Colorectal Cancer
Neurotoxicity
Interventions
First Posted Date
2011-01-19
Last Posted Date
2017-12-08
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
32
Registration Number
NCT01279681

Transanal Endoscopic Microsurgery (TEM) After Radiochemotherapy for Rectal Cancer

Phase 2
Completed
Conditions
Rectal Tumour
First Posted Date
2011-01-10
Last Posted Date
2017-04-14
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
55
Registration Number
NCT01273051
Locations
🇳🇱

Academisch Medisch Centrum, Amsterdam, Netherlands

🇳🇱

Slotervaart Ziekenhuis, Amsterdam, Netherlands

🇳🇱

Amphia Ziekenhuis, Breda, Netherlands

and more 10 locations

Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

Phase 1
Completed
Conditions
Rectal Neoplasms
Interventions
First Posted Date
2011-01-04
Last Posted Date
2015-04-06
Lead Sponsor
Chinese Academy of Medical Sciences
Target Recruit Count
18
Registration Number
NCT01268943
Locations
🇨🇳

radiation department, Cancer Hospital, CAMS, Beijing, Beijing, China

Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Phase 2
Terminated
Conditions
Stage IVA Oral Cavity Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Stage IVA Laryngeal Squamous Cell Carcinoma
Stage IVC Oropharyngeal Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Stage IVA Oropharyngeal Squamous Cell Carcinoma
Stage IVB Hypopharyngeal Squamous Cell Carcinoma
Stage IVB Laryngeal Squamous Cell Carcinoma
Stage IVB Oral Cavity Squamous Cell Carcinoma
Stage IVB Oropharyngeal Squamous Cell Carcinoma
Interventions
First Posted Date
2010-12-28
Last Posted Date
2017-04-14
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
25
Registration Number
NCT01267240
Locations
🇺🇸

Tower Cancer Research Foundation, Beverly Hills, California, United States

🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 11 locations

Cap+Bev vs Cap+Iri+Bev 1st-line Therapy in mCRC

Phase 3
Conditions
Colorectal Cancer Metastatic
Interventions
First Posted Date
2010-11-30
Last Posted Date
2011-03-14
Lead Sponsor
Ludwig-Maximilians - University of Munich
Target Recruit Count
516
Registration Number
NCT01249638
Locations
🇩🇪

University of Munich - Klinikum der Universitaet Muenchen, Munich, Germany

Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients

Phase 3
Withdrawn
Conditions
Hepatic Neoplasm Malignant
Interventions
First Posted Date
2010-11-22
Last Posted Date
2011-11-09
Lead Sponsor
Sanofi
Registration Number
NCT01245582

Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Biological: IMC-18F1
Biological: Ramucirumab DP
Drug: Capecitabine
First Posted Date
2010-11-04
Last Posted Date
2019-08-14
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
153
Registration Number
NCT01234402
Locations
🇨🇦

ImClone Investigational Site, Toronto, Ontario, Canada

Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-11-04
Last Posted Date
2018-11-06
Lead Sponsor
Bayer
Target Recruit Count
537
Registration Number
NCT01234337

Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors

Phase 1
Terminated
Conditions
Adenocarcinoma of the Pancreas
Adenocarcinoma of the Stomach
BRCA1 Mutation Carrier
BRCA2 Mutation Carrier
Ovarian Mucinous Cystadenocarcinoma
Recurrent Breast Cancer
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IIIA Breast Cancer
Recurrent Gastric Cancer
Interventions
Drug: veliparib
Drug: capecitabine
Drug: oxaliplatin
Other: pharmacological study
Other: laboratory biomarker analysis
First Posted Date
2010-11-03
Last Posted Date
2014-04-02
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
16
Registration Number
NCT01233505
Locations
🇺🇸

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer

Phase 2
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2010-11-01
Last Posted Date
2012-07-17
Lead Sponsor
Adherex Technologies, Inc.
Target Recruit Count
140
Registration Number
NCT01231802
Locations
🇷🇺

Chelyabinsk Regional Clinical Oncology, Chelyabinsk, Russian Federation

🇷🇺

Republic Oncology Center, Republic of Karelia, Russian Federation

🇷🇺

Stavropol Regional Clinical Oncology Center, Stavropol, Russian Federation

and more 13 locations
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