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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

Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer

Phase 2
Completed
Conditions
Stomach Neoplasms
Neoplasms Metastasis
ERBB2 Gene Amplification
Interventions
First Posted Date
2013-12-09
Last Posted Date
2016-11-18
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
67
Registration Number
NCT02004769
Locations
🇨🇳

Medical Oncology,Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Modified Folinic Acid-Fluorouracil-Oxaliplatin Regimen + Capecitabine for Elderly With Metastatic Gastric Cancer

Conditions
Metastatic Gastric Cancer
Interventions
Drug: FOLFOX
Drug: Capecitabine
First Posted Date
2013-12-05
Last Posted Date
2019-02-27
Lead Sponsor
International Group of Endovascular Oncology
Target Recruit Count
47
Registration Number
NCT02002195
Locations
🇮🇹

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore, Pesaro, PU, Italy

🇮🇹

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio San Salvatore,, Pesaro, Italy

STAR Cape+BKM120 MBC With Brain Met

Phase 2
Completed
Conditions
Brain Metastases
Metastatic Breast Cancer
Breast Cancer
Interventions
First Posted Date
2013-12-04
Last Posted Date
2022-02-07
Lead Sponsor
US Oncology Research
Target Recruit Count
10
Registration Number
NCT02000882
Locations
🇺🇸

Please contact Zuzanne Bristow for list of sites, Multiple Locations, Texas, United States

Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

Phase 2
Completed
Conditions
Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
Interventions
Drug: CDX-011
Drug: Capecitabine
First Posted Date
2013-11-28
Last Posted Date
2019-03-08
Lead Sponsor
Celldex Therapeutics
Target Recruit Count
327
Registration Number
NCT01997333
Locations
🇺🇸

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States

🇮🇹

Fondazione Policlinico Universitario A Gemelli, Roma, Lazio, Italy

🇪🇸

Hospital Regional Universitario de Malaga - Hospital General, Malaga, Málaga, Spain

and more 137 locations

A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

Phase 3
Completed
Conditions
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasm Metastasis
Interventions
First Posted Date
2013-11-27
Last Posted Date
2019-01-08
Lead Sponsor
Epidemiological and Clinical Research Information Network
Target Recruit Count
650
Registration Number
NCT01996306
Locations
🇯🇵

NPO Epidemiological and Clinical Research Information Network (ECRIN), Kyoto, Japan

Study of Andrographolides With or Without Capecitabine to Treat Colorectal Cancer

Phase 2
Terminated
Conditions
Colorectal Neoplasms
Interventions
Drug: Andrographolides
Drug: Capecitabine
First Posted Date
2013-11-25
Last Posted Date
2020-01-14
Lead Sponsor
Gu Yanhong
Target Recruit Count
308
Registration Number
NCT01993472
Locations
🇨🇳

the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC

Phase 2
Conditions
Gastric Cancer
Interventions
First Posted Date
2013-10-16
Last Posted Date
2013-10-16
Lead Sponsor
Fudan University
Target Recruit Count
120
Registration Number
NCT01963702
Locations
🇨🇳

Fudan University Cancer Hospital, Shanghai, Shanghai, China

Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient

Phase 1
Terminated
Conditions
Colorectal Cancer Metastatic
Interventions
First Posted Date
2013-10-07
Last Posted Date
2016-04-18
Lead Sponsor
Sanofi
Target Recruit Count
4
Registration Number
NCT01955629
Locations
🇮🇹

Investigational Site Number 380-001, Genova, Italy

🇮🇹

Investigational Site Number 380-002, Milano, Italy

Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Phase 3
Completed
Conditions
Malignant Neoplasm of Breast
Interventions
First Posted Date
2013-09-30
Last Posted Date
2019-05-02
Lead Sponsor
Pierre Fabre Medicament
Target Recruit Count
112
Registration Number
NCT01953003
Locations
🇸🇬

Gleneagles Hospital, Singapore, Singapore

🇸🇬

NUH, Singapore, Singapore

A Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.

Phase 2
Completed
Conditions
Anal Canal Cancer.
Interventions
Drug: Capecitabine
Drug: Mitomycins
Radiation: Radiotherapy
First Posted Date
2013-09-13
Last Posted Date
2014-03-28
Lead Sponsor
Instituto do Cancer do Estado de São Paulo
Target Recruit Count
51
Registration Number
NCT01941966
Locations
🇧🇷

ICESP, Sao Paulo, SP, Brazil

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