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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

Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

Phase 3
Terminated
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2014-04-21
Last Posted Date
2019-03-26
Lead Sponsor
Incyte Corporation
Target Recruit Count
321
Registration Number
NCT02117479

Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer

Phase 2
Conditions
Stage II Breast Cancer
Stage III Breast Cancer
Interventions
First Posted Date
2014-04-15
Last Posted Date
2014-04-15
Lead Sponsor
Guangxi Medical University
Target Recruit Count
100
Registration Number
NCT02115152
Locations
🇨🇳

Breast Cancer Surgery Department of Guangxi Medical University Cancer Center, Nanning, Guangxi, China

Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer

Phase 3
Completed
Conditions
Gastric Cancer
Interventions
Drug: Capecitabine/cisplatin
Drug: Capecitabine
Drug: S-1/cisplatin
Drug: S-1
Drug: Capecitabine/oxaliplatin
Drug: 5-fluorouracil
Drug: 5-fluorouracil/oxaliplatin
First Posted Date
2014-04-15
Last Posted Date
2020-10-23
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
111
Registration Number
NCT02114359
Locations
🇰🇷

Yeongnam University Medical Center, Daegu, Korea, Republic of

🇰🇷

Kyungpook National University Medical Center, Daegu, Korea, Republic of

🇰🇷

Inje University Haeundae Paik Hospital, Busan, Korea, Republic of

and more 11 locations

Capecitabine Plus Aflibercept as Maintenance Therapy Following Capecitabine Plus Oxaliplatin Plus Aflibercept in Patients With Metastatic Colorectal Cancer

Phase 2
Withdrawn
Conditions
Colorectal Cancer Metastatic
Interventions
First Posted Date
2014-03-12
Last Posted Date
2014-11-18
Lead Sponsor
Sanofi
Registration Number
NCT02085005

Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

Phase 2
Completed
Conditions
Metastatic Colorectal Cancer
Interventions
Drug: Sym004 (9/6 mg/kg)
Drug: Sym004 (12 mg/kg)
Other: Best Supportive Care (BSC)
Drug: Fluorouracil (5-FU)
Drug: Capecitabine
First Posted Date
2014-03-11
Last Posted Date
2019-04-16
Lead Sponsor
Symphogen A/S
Target Recruit Count
254
Registration Number
NCT02083653
Locations
🇺🇸

Mercy Research, Springfield, Missouri, United States

🇺🇸

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

🇺🇸

Hematology - Oncology Associates of Treasure Coast, Port Saint Lucie, Florida, United States

and more 51 locations

Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

Phase 3
Terminated
Conditions
Locally Advanced Unresectable Gastric Cancer
Metastatic Gastric Cancer
Interventions
First Posted Date
2014-03-03
Last Posted Date
2019-10-09
Lead Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Target Recruit Count
171
Registration Number
NCT02076594
Locations
🇮🇹

Ospedale L. Sacco, Milano, MI, Italy

🇮🇹

Osped. Di Circolo Serbelloni-Gorgonzola, Gorgonzola, MI, Italy

🇮🇹

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, BG, Italy

and more 22 locations

Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis

Phase 2
Completed
Conditions
Advanced Gastric Cancer
Interventions
First Posted Date
2014-02-25
Last Posted Date
2014-02-25
Lead Sponsor
Shanghai Zhongshan Hospital
Target Recruit Count
48
Registration Number
NCT02071043
Locations
🇨🇳

Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China

Recombinant Anti-tumor and Anti-virus Protein for Injection Plus Xeloda in Treatment of Metastatic Colorectal Cancer

Phase 2
Conditions
Metastatic Colorectal Cancer
Interventions
Drug: Novaferon
Drug: Capecitabine
First Posted Date
2014-02-21
Last Posted Date
2016-01-05
Lead Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Target Recruit Count
30
Registration Number
NCT02068131
Locations
🇨🇳

307 Hospital of PLA, Beijing, China

Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

Not Applicable
Conditions
Metastatic Colorectal Cancer
Interventions
Other: placebo
Drug: Capecitabine
First Posted Date
2014-01-23
Last Posted Date
2014-01-24
Lead Sponsor
Beijing Chao Yang Hospital
Target Recruit Count
80
Registration Number
NCT02043821

Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery

Phase 2
Completed
Conditions
BCLC Stage D Adult Hepatocellular Carcinoma
Recurrent Extrahepatic Bile Duct Carcinoma
Localized Non-Resectable Adult Liver Carcinoma
Stage III Childhood Hepatocellular Carcinoma
Stage IVA Gallbladder Cancer
Adult Cholangiocarcinoma
Advanced Adult Hepatocellular Carcinoma
Stage IV Childhood Hepatocellular Carcinoma
Recurrent Adult Liver Carcinoma
Stage IIIA Gallbladder Cancer
Interventions
First Posted Date
2014-01-22
Last Posted Date
2017-09-12
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
53
Registration Number
NCT02042443
Locations
🇺🇸

Las Vegas Cancer Center-Henderson, Henderson, Nevada, United States

🇺🇸

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, United States

🇺🇸

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

and more 291 locations
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