Capecitabine

Generic Name: Capecitabine

Brand Names: Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₂₂FN_₃O_₆

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

Clinical Trials

Radiation Therapy With Capecitabine in Rectal Cancer

Phase 2

Terminated

Conditions: Rectal Cancer

First Posted Date: 2005-09-15

Last Posted Date: 2008-01-10

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 30

Registration Number: NCT00176787

Locations: 🇺🇸
University of Michigan Cancer Center, Ann Arbor, Michigan, United States

Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

Phase 2

Completed

Conditions: Colorectal Adenocarcinoma

First Posted Date: 2005-09-14

Last Posted Date: 2007-12-21

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 37

Registration Number: NCT00165217

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

First Posted Date: 2005-09-12

Last Posted Date: 2013-02-07

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 40

Registration Number: NCT00153907

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Evaluation of Tumor Factors in Breast Cancer Treated With Docetaxel and Capecitabine

Not Applicable

Completed

Conditions: Breast Cancer

First Posted Date: 2005-09-12

Last Posted Date: 2012-02-07

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 25

Registration Number: NCT00156312

Locations: 🇺🇸
University of Michigan Cancer Center, Ann Arbor, Michigan, United States

Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases

Phase 3

Conditions: Colorectal Neoplasms
Liver Metastases

First Posted Date: 2005-09-12

Last Posted Date: 2009-12-25

Lead Sponsor: Arbeitsgruppe Lebermetastasen und Tumoren

Target Recruit Count: 384

Registration Number: NCT00156975

Locations: 🇩🇪
Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II, Essen, Germany
🇩🇪
Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik, Dresden, Sachsen, Germany
🇩🇪
Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität, Frankfurt Am Main, Germany

Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Oxaliplatin
Drug: Bevacizumab
Drug: Capecitabine

First Posted Date: 2005-09-12

Last Posted Date: 2014-07-29

Lead Sponsor: University of Southern California

Target Recruit Count: 63

Registration Number: NCT00159432

Locations: 🇺🇸
U.S.C./Norris Comprehensive Cancer Center, Los Angeles, California, United States

Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Drug: Capecitabine
Drug: Docetaxel

First Posted Date: 2005-09-08

Last Posted Date: 2015-01-21

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 15

Registration Number: NCT00151047

Locations: 🇺🇸
Wayne State University, Detroit, Michigan, United States
🇺🇸
The University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

TBP Study With Capecitabine Plus Minus Trastuzumab

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Capecitabine
Drug: Trastuzumab

First Posted Date: 2005-09-08

Last Posted Date: 2011-02-23

Lead Sponsor: German Breast Group

Target Recruit Count: 482

Registration Number: NCT00148876

Locations: 🇩🇪
Johann Wolfgang Goethe Universität, Universitätsfrauenklinik, Frankfurt / Main, Hessen, Germany

Capecitabine in Women With Operable Breast Cancer

Phase 2

Terminated

Conditions: Invasive Breast Carcinoma
Primary Invasive Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Stage I Breast Cancer

First Posted Date: 2005-09-08

Last Posted Date: 2015-11-11

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 80

Registration Number: NCT00148720

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Faulkner Hospital, Boston, Massachusetts, United States

A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer

Phase 2

Completed

Conditions: Head and Neck Cancer

Interventions: Drug: Docetaxel
Drug: Capecitabine

First Posted Date: 2005-09-07

Last Posted Date: 2014-04-17

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 40

Registration Number: NCT00148122

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

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