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, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma

Phase 1

Completed

Conditions: Cholangiocarcinoma

First Posted Date: 2006-07-11

Last Posted Date: 2008-08-26

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 39

Registration Number: NCT00350961

Locations: 🇩🇰
Rigshospitalet, Copenhagen, Denmark
🇩🇰
Vejle Sygehus, Vejle, Denmark

Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2006-07-04

Last Posted Date: 2015-12-14

Lead Sponsor: University of Chicago

Target Recruit Count: 18

Registration Number: NCT00347438

Locations: 🇳🇬
Obafemi Awolowo University, Ile-Ife, Nigeria
🇺🇸
University of Chicago, Chicago, Illinois, United States
🇳🇬
University of Ibadan, Ibadan, Nigeria

Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2006-06-28

Last Posted Date: 2010-08-16

Lead Sponsor: Chugai Pharmaceutical

Target Recruit Count: 64

Registration Number: NCT00345761

Locations: 🇯🇵
Tokai Region, Tokai, Japan
🇯🇵
Hokkaido Region, Hokkaido, Japan
🇯🇵
Kanto Region, Kanto, Japan

and more 1 locations

1stline Study Capecitabine Administered on Continuous Way Plus Oxaliplatin&Bevacizumab Every 2weeks in Metastatic CCR.

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

First Posted Date: 2006-06-28

Last Posted Date: 2011-08-24

Lead Sponsor: Unidad Integral de Investigación en Oncología S.L.

Target Recruit Count: 32

Registration Number: NCT00345696

Locations: 🇪🇸
Hospital 12 de Octubre, Madrid, Spain

The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

Phase 3

Terminated

Conditions: Advanced Non-Small Cell Lung Cancer

Interventions: Drug: docetaxel
Drug: capecitabine
Drug: vinorelbine
Drug: gemcitabine

First Posted Date: 2006-06-27

Last Posted Date: 2016-01-14

Lead Sponsor: National Cancer Institute, Naples

Target Recruit Count: 84

Registration Number: NCT00345059

Locations: 🇮🇹
Ospedali Riuniti, Foggia, FG, Italy
🇮🇹
Ospedale Civile di Legnano, Legnano, MI, Italy
🇮🇹
Ospedale S. Paolo, Milano, MI, Italy

and more 21 locations

Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

Phase 2

Completed

Conditions: Cancer of the Gallbladder
Cancer of the Biliary Tract

Interventions: Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2006-06-20

Last Posted Date: 2012-08-01

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 44

Registration Number: NCT00338988

Locations: 🇺🇸
U.T. M.D. Anderson Cancer Center, Houston, Texas, United States

Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Cetuximab
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Capecitabine
Radiation: Radiotherapy

First Posted Date: 2006-06-20

Last Posted Date: 2013-03-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 69

Registration Number: NCT00338039

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

Phase 3

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Eribulin Mesylate
Drug: Capecitabine

First Posted Date: 2006-06-15

Last Posted Date: 2020-06-18

Lead Sponsor: Eisai Inc.

Target Recruit Count: 1276

Registration Number: NCT00337103

Locations: 🇧🇪
Institut Jules Bordet, Medical Oncology Unit, Brussels, Belgium
🇦🇺
Royal Perth Hospital, Perth, Western Australia, Australia
🇦🇺
Bankstown Hospital, Oncology Trials Unit, Bankstown, New South Wales, Australia

and more 65 locations

S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery

Phase 2

Terminated

Conditions: Gastric Cancer

Interventions: Drug: capecitabine
Drug: oxaliplatin
Procedure: conventional surgery
Radiation: radiation therapy

First Posted Date: 2006-06-12

Last Posted Date: 2012-08-17

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 7

Registration Number: NCT00335959

Locations: 🇺🇸
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
🇺🇸
Munson Medical Center, Traverse City, Michigan, United States
🇺🇸
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler, Savannah, Georgia, United States

and more 71 locations

Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer
Cancer

Interventions: Drug: larotaxel
Drug: capecitabine

First Posted Date: 2006-05-18

Last Posted Date: 2016-05-18

Lead Sponsor: Sanofi

Target Recruit Count: 34

Registration Number: NCT00327743

Locations: 🇫🇷
Sanofi-Aventis Administrative Office, Paris, France

Drug Development Updates

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