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

Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer

Phase 2

Completed

Conditions: Breast Neoplasm

Interventions: Drug: Vinorelbine
Drug: Capecitabine

First Posted Date: 2005-09-19

Last Posted Date: 2012-09-13

Lead Sponsor: University of Washington

Target Recruit Count: 40

Registration Number: NCT00194727

Locations: 🇺🇸
University of Washington; Seattle Cancer Care Alliance, Seattle, Washington, United States

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

Phase 2

Terminated

Conditions: Estrogen Receptor-positive Breast Cancer
Stage IIIA Breast Cancer
HER2-negative Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer

Interventions: Drug: exemestane
Drug: triptorelin pamoate
Drug: capecitabine
Drug: methotrexate
Drug: vinorelbine tartrate
Drug: paclitaxel
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Other: laboratory biomarker analysis

First Posted Date: 2005-09-19

Last Posted Date: 2017-07-11

Lead Sponsor: University of Washington

Target Recruit Count: 28

Registration Number: NCT00194792

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

First Posted Date: 2005-09-19

Last Posted Date: 2018-03-12

Lead Sponsor: University of Washington

Target Recruit Count: 50

Registration Number: NCT00194779

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

Phase 1

Completed

Conditions: Esophagus Cancer

Interventions: Drug: Oxaliplatin
Drug: Docetaxel
Radiation: Radiation therapy
Drug: Capecitabine

First Posted Date: 2005-09-19

Last Posted Date: 2021-11-24

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 59

Registration Number: NCT00193128

Locations: 🇺🇸
Atlanta Cancer Care, Atlanta, Georgia, United States
🇺🇸
Northeast Georgia Medical Center, Gainesville, Georgia, United States
🇺🇸
Integrated Community Oncology Network, Jacksonville, Florida, United States

and more 4 locations

A Phase III Trial For Patients With Metastatic Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer
Breast Neoplasms
Cancer of the Breast

Interventions: Drug: docetaxel
Drug: gemcitabine
Drug: capecitabine

First Posted Date: 2005-09-19

Last Posted Date: 2009-12-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 475

Registration Number: NCT00191152

Locations: 🇲🇽
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Michoacan, Mexico
🇨🇳
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician., Taipei, Taiwan
🇨🇳
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph, Tao-Yuan, Taiwan

and more 1 locations

Combination Chemotherapy With or Without Cetuximab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

Phase 3

Conditions: Colorectal Cancer

First Posted Date: 2005-09-16

Last Posted Date: 2013-09-17

Lead Sponsor: Velindre NHS Trust

Target Recruit Count: 2421

Registration Number: NCT00182715

Locations: 🇮🇪
Mater Misericordiae University Hospital, Dublin, Ireland
🇬🇧
Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England, United Kingdom
🇬🇧
University College of London Hospitals, London, England, United Kingdom

and more 78 locations