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

Gemcitabine With/Out Capecitabine in Locally Advanced, Unresectable, or Metastatic Biliary Cancer

Phase 3

Terminated

Conditions: Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer

Interventions: Drug: capecitabine
Drug: gemcitabine hydrochloride
Procedure: quality-of-life assessment

First Posted Date: 2008-04-15

Last Posted Date: 2023-08-04

Lead Sponsor: NCIC Clinical Trials Group

Target Recruit Count: 19

Registration Number: NCT00658593

Locations: 🇨🇦
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇨🇦
Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada

and more 5 locations

Fluorouracil and Oxaliplatin With or Without Panitumumab In Treating Patients With High-Risk Colon Cancer That Can Be Removed by Surgery

Phase 2

Conditions: Colorectal Cancer

Interventions: Biological: panitumumab
Drug: capecitabine
Drug: fluorouracil
Drug: oxaliplatin

First Posted Date: 2008-03-31

Last Posted Date: 2019-05-17

Lead Sponsor: University of Birmingham

Target Recruit Count: 1053

Registration Number: NCT00647530

Locations: 🇬🇧
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom
🇬🇧
Derriford Hospital, Plymouth, England, United Kingdom
🇬🇧
Queen Elizabeth Hospital, Gateshead, England, United Kingdom

and more 7 locations

Epirubicin, Docetaxel, and Capecitabine in Treating Women With Stage IIIA or Stage IIIB Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

First Posted Date: 2008-03-28

Last Posted Date: 2011-05-16

Lead Sponsor: Mayo Clinic

Target Recruit Count: 47

Registration Number: NCT00645866

Combination Chemotherapy and Cetuximab as First-Line Therapy in Treating Patients With Advanced and/or Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: cetuximab
Drug: capecitabine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

First Posted Date: 2008-03-20

Last Posted Date: 2021-09-22

Lead Sponsor: Cheryl Pugh

Target Recruit Count: 169

Registration Number: NCT00640081

Locations: 🇬🇧
Weston Park, Sheffield, United Kingdom
🇬🇧
Darent Valley Hospital, Dartford, United Kingdom
🇬🇧
Guys and St Thomas' hospitals, London, United Kingdom

and more 22 locations

Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

Phase 3

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: capecitabine
Drug: gemcitabine hydrochloride
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Radiation: radiation therapy

First Posted Date: 2008-03-13

Last Posted Date: 2015-12-11

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Target Recruit Count: 820

Registration Number: NCT00634725

Locations: 🇫🇷
Clinique De Valdegour, Nimes, France
🇫🇷
Hopital Prive Jean Mermoz, Lyon, France
🇫🇷
Institut Sainte Catherine, Avignon, France

and more 69 locations

CO07204-Phase I/II of Oxaliplatin, Capecitabine & Sorafenib for Advanced Pancreatic & Biliary Carcinoma

Phase 1

Completed

Conditions: Pancreatic Neoplasms
Bile Duct Neoplasms

Interventions: Drug: Oxaliplatin
Drug: Capecitabine
Drug: Sorafenib

First Posted Date: 2008-03-13

Last Posted Date: 2019-11-26

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 48

Registration Number: NCT00634751

Locations: 🇺🇸
University of Wisconsin, Madison, Wisconsin, United States

LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: LBH589
Drug: Capecitabine
Drug: Lapatinib

First Posted Date: 2008-03-10

Last Posted Date: 2015-06-08

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 20

Registration Number: NCT00632489

Locations: 🇺🇸
Tennessee Oncology, PLLC, Nashville, Tennessee, United States

Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers

Phase 1

Completed

Conditions: Pancreatic Cancer
Biliary Cancer

Interventions: Drug: gemcitabine
Drug: capecitabine

First Posted Date: 2008-02-29

Last Posted Date: 2012-04-04

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 45

Registration Number: NCT00626158

Locations: 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
🇺🇸
Huntsman Cancer Center, University of Utah, Salt Lake City, Utah, United States

Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Dietary Supplement: selenomethionine
Drug: capecitabine
Drug: oxaliplatin
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy