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, Capecitabine, and Bevacizumab in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

Not Applicable

Withdrawn

Conditions: Pancreatic Cancer

First Posted Date: 2007-09-03

Last Posted Date: 2013-02-01

Lead Sponsor: Roswell Park Cancer Institute

Registration Number: NCT00524069

Phase II Efficacy Study of AZD6244 in Colorectal Cancer

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: AZD6244
Drug: Capecitabine

First Posted Date: 2007-08-10

Last Posted Date: 2014-08-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 64

Registration Number: NCT00514761

Locations: 🇧🇷
Research Site, Sao Paulo, Brazil

Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase 2

Conditions: Lung Cancer

First Posted Date: 2007-08-09

Last Posted Date: 2014-01-10

Lead Sponsor: Raghu Nandan, M.D., Inc

Target Recruit Count: 39

Registration Number: NCT00514293

Locations: 🇺🇸
R. Nandan M.D. Incorporated, Lakewood, California, United States

Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer

Phase 2

Conditions: Esophageal Cancer

Interventions: Drug: capecitabine
Biological: cetuximab
Drug: cisplatin
Radiation: radiation therapy

First Posted Date: 2007-07-31

Last Posted Date: 2012-12-18

Lead Sponsor: Wales Cancer Trials Unit

Target Recruit Count: 259

Registration Number: NCT00509561

Locations: 🇬🇧
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
🇬🇧
Addenbrooke's Hospital, Cambridge, England, United Kingdom
🇬🇧
Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham, England, United Kingdom

and more 52 locations

Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China

Phase 3

Terminated

Conditions: Neoplasms, Breast

Interventions: Drug: lapatinib
Drug: capecitabine

First Posted Date: 2007-07-27

Last Posted Date: 2021-09-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 52

Registration Number: NCT00508274

Locations: 🇭🇰
Novartis Investigative Site, Shatin, Hong Kong

6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients

Phase 2

Completed

Conditions: Glioblastoma Multiforme
Anaplastic Glioma of Brain
Brain Cancer

Interventions: Drug: Capecitabine
Drug: Celecoxib (Celebrex)
Drug: Temozolomide
Drug: Lomustine
Drug: 6-Thioguanine

First Posted Date: 2007-07-20

Last Posted Date: 2012-01-11

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 75

Registration Number: NCT00504660

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

Proton Therapy With Capecitabine for Rectal Cancer

Phase 1

Withdrawn

Conditions: Rectal Cancer

Interventions: Procedure: Proton Therapy
Drug: Capecitabine

First Posted Date: 2007-07-19

Last Posted Date: 2012-03-22

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT00503932

Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
HER2/Neu-positive Breast Cancer

Interventions: Drug: Capecitabine
Drug: Lapatinib

First Posted Date: 2007-07-04

Last Posted Date: 2017-03-21

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 11

Registration Number: NCT00496366

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Rutgers Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey, United States