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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

An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer

Completed
Conditions
Colorectal Cancer
Interventions
Drug: Capecitabine
Biological: Oxaliplatin
First Posted Date
2011-09-28
Last Posted Date
2016-07-07
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
74
Registration Number
NCT01442155

Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

Phase 2
Completed
Conditions
Estrogen Receptor Positive Tumor
Breast Cancer
Interventions
First Posted Date
2011-09-23
Last Posted Date
2023-06-22
Lead Sponsor
Eisai Inc.
Target Recruit Count
77
Registration Number
NCT01439282
Locations
🇺🇸

New York Oncology Hematology, P.C., Albany, New York, United States

🇺🇸

Arizona Oncology Associates, PC - CASA, Tucson, Arizona, United States

🇺🇸

Sciode Medical Associates, PLLC, d.b.a. Eastchester Center, Bronx, New York, United States

and more 20 locations

Epirubicin and Paclitaxel, Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer

Phase 3
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2011-09-14
Last Posted Date
2015-09-17
Lead Sponsor
Thomas Hatschek
Target Recruit Count
304
Registration Number
NCT01433614
Locations
🇸🇪

Sahlgrenska University Hospital, Göteborg, Sweden

🇸🇪

Kalmar Central Hospital, Kalmar, Sweden

🇸🇪

Helsingborg Gen. Hospital, Helsingborg, Sweden

and more 6 locations

Study of Ruxolitinib in Pancreatic Cancer Patients

Phase 2
Completed
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2011-08-26
Last Posted Date
2018-02-12
Lead Sponsor
Incyte Corporation
Target Recruit Count
136
Registration Number
NCT01423604

Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

Phase 1
Completed
Conditions
Esophageal Cancer
Malignant Neoplasm of Cardio-esophageal Junction of Stomach
Interventions
First Posted Date
2011-07-01
Last Posted Date
2018-12-12
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
12
Registration Number
NCT01386346
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma

Phase 2
Completed
Conditions
Pancreatic Cancer
Interventions
Drug: Gemcitabine
Drug: Capecitabine
Radiation: Stereotactic Body Radiation Therapy (SBRT)
First Posted Date
2011-05-25
Last Posted Date
2022-03-08
Lead Sponsor
David A. Clump, MD, PhD
Target Recruit Count
35
Registration Number
NCT01360593
Locations
🇺🇸

UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States

E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer

Phase 1
Terminated
Conditions
Advanced or Metastatic Solid Tumors
Previously Untreated Gastric Cancer
Interventions
First Posted Date
2011-05-18
Last Posted Date
2017-05-15
Lead Sponsor
Eisai Inc.
Target Recruit Count
7
Registration Number
NCT01355302
Locations
🇺🇸

Boca Raton Clinical Research Associates, Inc, Plantation, Florida, United States

🇺🇸

Robert H. Lurie Comprenhensive Cancer Center of Northwestern University, Chicago, Illinois, United States

🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

and more 16 locations

Investigational Drug in Combination With Two Chemotherapy Drugs in Women With Locally Recurrent or Metastatic Breast Cancer

Phase 1
Withdrawn
Conditions
Metastatic Breast Cancer
Stage IV Breast Cancer
Breast Cancer
Interventions
First Posted Date
2011-05-06
Last Posted Date
2016-10-21
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Registration Number
NCT01349088
Locations
🇺🇸

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

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