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

S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin
Procedure: therapeutic surgical procedure
Radiation: radiation therapy

First Posted Date: 2008-05-29

Last Posted Date: 2018-05-18

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 83

Registration Number: NCT00686166

Locations: 🇺🇸
Cancer Center of Kansas-Independence, Independence, Kansas, United States
🇺🇸
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
🇺🇸
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

and more 127 locations

Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer

Phase 2

Completed

Conditions: HER2 Positive Breast Carcinoma
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
Stage IV Breast Cancer AJCC v6 and v7

Interventions: Drug: Capecitabine
Drug: Lapatinib Ditosylate
Biological: Cixutumumab
Other: Quality-of-Life Assessment

First Posted Date: 2008-05-28

Last Posted Date: 2020-03-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 64

Registration Number: NCT00684983

Locations: 🇺🇸
Swedish Medical Center, Englewood, Colorado, United States
🇺🇸
Contra Costa Regional Medical Center, Martinez, California, United States
🇺🇸
MultiCare Good Samaritan Hospital, Puyallup, Washington, United States

and more 385 locations

Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: capecitabine
Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

First Posted Date: 2008-05-26

Last Posted Date: 2017-09-14

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 10

Registration Number: NCT00684216

Locations: 🇳🇱
NKI-AVL, Amsterdam, Netherlands

LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

Phase 3

Completed

Conditions: Neoplasms, Gastrointestinal Tract

Interventions: Drug: Lapatinib
Drug: Placebo
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2008-05-20

Last Posted Date: 2024-10-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 545

Registration Number: NCT00680901

Locations: 🇺🇦
Novartis Investigative Site, Zaporizhzhia, Ukraine

Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer

Phase 3

Completed

Conditions: Gastric Cancer

Interventions: Drug: Cetuximab
Drug: Capecitabine
Drug: Cisplatin

First Posted Date: 2008-05-15

Last Posted Date: 2014-07-21

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 904

Registration Number: NCT00678535

Locations: 🇬🇧
Research site, Manchester, United Kingdom
🇨🇳
Research Site, Taipei, Taiwan

NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colon Cancer

Interventions: Drug: NGR-hTNF
Drug: Oxaliplatin
Drug: capecitabine

First Posted Date: 2008-05-08

Last Posted Date: 2014-05-30

Lead Sponsor: AGC Biologics S.p.A.

Target Recruit Count: 24

Registration Number: NCT00675012

Locations: 🇮🇹
Azienda Ospedaliera Universitaria San Martino, Genoa, Italy

The Effect of Preoperative Docetaxel, Cisplatin and Capecitabine on Serum RUNX3 Hypermethylation Status in Patients With Gastric and Lower Oesophagus Adenocarcinoma

Phase 2

Conditions: Gastric Cancer

Interventions: Drug: Docetaxel
Drug: Cisplatin
Drug: Capecitabine

First Posted Date: 2008-05-07

Last Posted Date: 2015-06-12

Lead Sponsor: National University Hospital, Singapore

Target Recruit Count: 21

Registration Number: NCT00674167

Locations: 🇸🇬
National University Hospital, Singapore, Singapore

Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Biological: filgrastim
Drug: capecitabine
Drug: celecoxib
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Genetic: gene expression analysis
Genetic: polymorphism analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: imaging biomarker analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: needle biopsy
Procedure: neoadjuvant therapy
Procedure: radiomammography
Procedure: ultrasound imaging