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

Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: capecitabine
Drug: lapatinib ditosylate

First Posted Date: 2009-08-20

Last Posted Date: 2014-12-31

Lead Sponsor: Cancer Trials Ireland

Target Recruit Count: 9

Registration Number: NCT00962312

Locations: 🇮🇪
Mater Private Hospital, Dublin, Ireland
🇮🇪
St. Vincent's University Hospital, Dublin, Ireland
🇮🇪
Beaumont Hospital, Dublin, Ireland

and more 6 locations

Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism

Phase 2

Withdrawn

Conditions: Breast Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2009-08-18

Last Posted Date: 2019-06-14

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT00960544

Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer

Phase 1

Terminated

Conditions: Advanced Breast Cancer (Parts 1 and 2)
Advanced Pancreatic Cancer (Part 1)
Advanced Colorectal Cancer (Part 1)
Advanced Cholangiocarcinoma (Part 1)
Advanced Glioblastoma Multiforme (Part 1)

Interventions: Drug: Bosutinib
Drug: Capecitabine

First Posted Date: 2009-08-17

Last Posted Date: 2013-02-22

Lead Sponsor: Pfizer

Target Recruit Count: 32

Registration Number: NCT00959946

Locations: 🇪🇸
Pfizer Investigational Site, Madrid, Spain

Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients

Phase 1

Completed

Conditions: Gastric Cancer

Interventions: Drug: Cediranib
Drug: Cisplatin
Drug: S-1
Drug: Capecitabine

First Posted Date: 2009-08-17

Last Posted Date: 2011-06-14

Lead Sponsor: AstraZeneca

Target Recruit Count: 14

Registration Number: NCT00960349

Locations: 🇯🇵
Research Site, Chuo, Tokyo, Japan

Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: gemcitabine hydrochloride
Drug: capecitabine
Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil

First Posted Date: 2009-08-17

Last Posted Date: 2012-01-13

Lead Sponsor: IRCCS San Raffaele

Target Recruit Count: 102

Registration Number: NCT00960284

Locations: 🇮🇹
Istituto Scientifico H. San Raffaele, Milan, Italy

Predicting Response to Capecitabine in Women With Metastatic Breast Cancer

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Drug: capecitabine
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2009-08-06

Last Posted Date: 2015-02-10

Lead Sponsor: Centre Antoine Lacassagne

Target Recruit Count: 303

Registration Number: NCT00953537

Locations: 🇫🇷
Centre Antoine Lacassagne, Nice, France

Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Phase 2

Completed

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Gastric Cancer

Interventions: Drug: fluorouracil
Drug: capecitabine
Drug: docetaxel
Drug: oxaliplatin
Radiation: radiation therapy
Procedure: therapeutic conventional surgery

First Posted Date: 2009-07-13

Last Posted Date: 2018-03-29

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 73

Registration Number: NCT00938470

Locations: 🇺🇸
Graham Hospital, Canton, Illinois, United States
🇺🇸
Illinois CancerCare - Galesburg, Galesburg, Illinois, United States
🇺🇸
Mason District Hospital, Havana, Illinois, United States

and more 182 locations

XAD - Xelox (Capecitabine + Oxaliplatin) + Bevacizumab + Dasatinib

Phase 1

Completed

Conditions: Solid Tumor
Metastatic Colorectal Cancer

Interventions: Drug: dasatinib
Drug: bevacizumab
Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2009-06-15

Last Posted Date: 2016-02-03

Lead Sponsor: Herbert Hurwitz, MD

Target Recruit Count: 22

Registration Number: NCT00920868

Locations: 🇺🇸
Rocky Mountain Cancer Center, Denver, Colorado, United States
🇺🇸
Duke Univeristy Medical Center, Durham, North Carolina, United States