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

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Neratinib
Drug: Capecitabine

First Posted Date: 2008-08-26

Last Posted Date: 2018-09-05

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 105

Registration Number: NCT00741260

Locations: 🇦🇺
Border Medical Oncology, Wodonga, Victoria, Australia
🇭🇷
University Hospital Center Zagreb Department of Oncology, Zagreb, Croatia
🇷🇺
Saint-Petersburg State Medical University n.a. acad. I.P. Pavlov, Laboratory of Thoracic Oncology of Pulmonology Research Institute, Saint Petersburg, Russian Federation

and more 34 locations

SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716)

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung
Breast Neoplasms

Interventions: Drug: Erlotinib
Drug: SCH 727965
Drug: Capecitabine

First Posted Date: 2008-08-12

Last Posted Date: 2015-08-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 97

Registration Number: NCT00732810

Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors

Phase 1

Conditions: Advanced Solid Tumors

Interventions: Drug: indibulin
Drug: capecitabine

First Posted Date: 2008-08-01

Last Posted Date: 2012-07-19

Lead Sponsor: Alaunos Therapeutics

Target Recruit Count: 7

Registration Number: NCT00726687

AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer

Phase 1

Completed

Conditions: Gastric Cancer
Esophageal Cancer
Esophagogastric Junction Adenocarcinoma

Interventions: Drug: Capecitabine
Drug: Epirubicin
Drug: Cisplatin
Drug: AMG 102
Drug: Placebo

First Posted Date: 2008-07-21

Last Posted Date: 2013-12-05

Lead Sponsor: Amgen

Target Recruit Count: 130

Registration Number: NCT00719550

Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

Phase 2

Completed

Conditions: Gastric Cancer

Interventions: Drug: Docetaxel
Drug: Cisplatin
Drug: Capecitabine
Radiation: Radiation

First Posted Date: 2008-07-21

Last Posted Date: 2015-05-18

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 40

Registration Number: NCT00718913

Locations: 🇬🇷
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece
🇬🇷
University Hospital of Crete Dept of Medical Oncology, Heraklion, Crete, Greece
🇬🇷
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece

and more 5 locations

Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Capecitabine
Drug: Bevacizumab
Drug: Irinotecan

First Posted Date: 2008-07-18

Last Posted Date: 2015-10-07

Lead Sponsor: University Hospital of Crete

Target Recruit Count: 15

Registration Number: NCT00717990

Locations: 🇬🇷
University Hospital of Crete, Dep of Medical Oncology, Heraklion, Greece

Study of Capecitabine to Treat Recurrent High Grade Gliomas

Phase 2

Completed

Conditions: Malignant Glioma

Interventions: Drug: Capecitabine

First Posted Date: 2008-07-17

Last Posted Date: 2013-07-02

Lead Sponsor: University of Florida

Target Recruit Count: 30

Registration Number: NCT00717197

Locations: 🇺🇸
University of Florida, Gainesville, Florida, United States

Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma

Phase 1

Completed

Conditions: Cancer
Pancreas

Interventions: Radiation: Radiation Therapy
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2008-06-30

Last Posted Date: 2014-10-31

Lead Sponsor: University of Utah

Target Recruit Count: 13

Registration Number: NCT00707278

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer

Phase 1

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Vinorelbine oral
Drug: Capecitabine

First Posted Date: 2008-06-27

Last Posted Date: 2009-12-15

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 40

Registration Number: NCT00706069

Locations: 🇬🇷
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece
🇬🇷
University General Hospital of Alexandroupolis, Dept. of Medical Oncology, Alexandroupolis, Greece
🇬🇷
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology, Athens, Greece

and more 1 locations

Study of Capecitabine In Patients With Solid Tumors

Phase 1

Completed

Conditions: Solid Tumors

Interventions: Drug: Capecitabine

First Posted Date: 2008-06-16

Last Posted Date: 2012-11-01

Lead Sponsor: National University Hospital, Singapore

Target Recruit Count: 23

Registration Number: NCT00697502

Locations: 🇸🇬
National University Hospital, Singapore, Singapore

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