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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

A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2012-05-01
Last Posted Date
2017-02-27
Lead Sponsor
Tao OUYANG
Target Recruit Count
54
Registration Number
NCT01589159
Locations
🇨🇳

Peking University Cancer Hospital & Institute, Beijing, Beijing, China

A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer

Phase 4
Completed
Conditions
Colorectal Neoplasms
Interventions
First Posted Date
2012-05-01
Last Posted Date
2019-01-22
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
128
Registration Number
NCT01588990
Locations
🇦🇺

Calvary North Adelaide; North Adeliade Oncology Centre, North Adelaide, South Australia, Australia

🇦🇺

Canberra Hospital, Garran, Australian Capital Territory, Australia

🇦🇺

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

and more 14 locations

Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

Phase 1
Completed
Conditions
Rectal Neoplasms
Interventions
First Posted Date
2012-04-25
Last Posted Date
2015-04-20
Lead Sponsor
Chinese Academy of Medical Sciences
Target Recruit Count
24
Registration Number
NCT01584544
Locations
🇨🇳

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

Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer

Phase 2
Conditions
Gastric Carcinoma
Interventions
First Posted Date
2012-04-09
Last Posted Date
2012-07-24
Lead Sponsor
Genta Incorporated
Target Recruit Count
580
Registration Number
NCT01573468
Locations
🇩🇪

Krankenhaus Nordwest, Frankfurt, Germany

🇺🇸

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

🇨🇳

National Cheng Kung University Hospital, Tainan, Taiwan

Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma

Phase 2
Completed
Conditions
Pancreatic Adenocarcinoma
Interventions
First Posted Date
2012-03-20
Last Posted Date
2017-05-09
Lead Sponsor
The University of Hong Kong
Target Recruit Count
37
Registration Number
NCT01558869
Locations
🇭🇰

Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong

Efficacy and Safety Study of a Modified XELOX Regimen in First-Line Treatment of Metastatic Colorectal Adenocarcinoma

Phase 2
Conditions
Colorectal Adenocarcinoma
First Posted Date
2012-03-13
Last Posted Date
2012-03-28
Lead Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Target Recruit Count
30
Registration Number
NCT01552967
Locations
🇨🇳

the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy

Not Applicable
Conditions
Hilar Cholangiocarcinoma
Primary Sclerosing Cholangitis
First Posted Date
2012-03-09
Last Posted Date
2012-07-18
Lead Sponsor
Azienda Ospedaliera di Padova
Target Recruit Count
33
Registration Number
NCT01549795
Locations
🇮🇹

Azienda Ospedaliera di Padova, Padova, Italy

Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer

Phase 2
Completed
Conditions
Extrahepatic Bile Duct Cancer
Nausea
Vomiting
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Interventions
Drug: aprepitant
Drug: gemcitabine hydrochloride
Drug: capecitabine
Drug: fluorouracil
Procedure: radiation therapy
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: nausea and vomiting therapy
Procedure: management of therapy complications
First Posted Date
2012-02-17
Last Posted Date
2018-08-15
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
22
Registration Number
NCT01534637
Locations
🇺🇸

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Second Line Therapy in Advanced Biliary Tract Cancer

Phase 2
Completed
Conditions
Biliary Tract Cancer
Interventions
First Posted Date
2012-02-10
Last Posted Date
2016-02-25
Lead Sponsor
IRCCS San Raffaele
Target Recruit Count
52
Registration Number
NCT01530503
Locations
🇮🇹

Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi, Bologna, Italy

🇮🇹

A.O. Ospedali Riuniti, Bergamo, Italy

🇮🇹

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G Salesi, Ancona, Italy

and more 13 locations

Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors

Phase 2
Completed
Conditions
Gastrinoma
Pancreatic Polypeptide Tumor
Recurrent Islet Cell Carcinoma
Glucagonoma
Insulinoma
Recurrent Pancreatic Cancer
Somatostatinoma
Stage IV Pancreatic Cancer
Stage III Pancreatic Cancer
Interventions
First Posted Date
2012-02-02
Last Posted Date
2024-02-06
Lead Sponsor
Shaheen Shagufta
Target Recruit Count
20
Registration Number
NCT01525082
Locations
🇺🇸

Stanford University Medical Center, Stanford, California, United States

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