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

Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

Phase 2

Completed

Conditions: Resectable Rectal Cancer Clinical Stage II and III

First Posted Date: 2010-06-29

Last Posted Date: 2010-06-29

Lead Sponsor: Institute of Oncology Ljubljana

Target Recruit Count: 57

Registration Number: NCT01152710

Locations: 🇸🇮
Institute of Oncology, Ljubljana, Slovenia

Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation

Phase 2

Terminated

Conditions: Cholangiocarcinoma
Hepatobiliary Neoplasm
Liver Cancer
Bile Duct Cancer
Cancer of Gallbladder

Interventions: Procedure: Stereotactic Body Radiotherapy
Drug: Gemcitabine
Drug: Cisplatin
Drug: Carboplatin
Drug: Capecitabine
Drug: 5FU
Procedure: Liver transplantation

First Posted Date: 2010-06-28

Last Posted Date: 2016-07-29

Lead Sponsor: Stanford University

Target Recruit Count: 2

Registration Number: NCT01151761

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Treating Patients With Stage I-II Resectable Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: capecitabine
Drug: cisplatin
Drug: epirubicin
Drug: gemcitabine

First Posted Date: 2010-06-25

Last Posted Date: 2017-09-01

Lead Sponsor: IRCCS San Raffaele

Target Recruit Count: 98

Registration Number: NCT01150630

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

A Phase I Study of AZD6244 in Combination With Capecitabine and Radiotherapy in Locally Advanced Adenocarcinoma of the Rectum

Phase 1

Terminated

Conditions: Non-Metastatic Adenocarcinoma of the Rectum

Interventions: Procedure: Radiation Therapy
Drug: Capecitabine
Drug: AZD6244

First Posted Date: 2010-06-02

Last Posted Date: 2021-12-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT01134601

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer

Phase 1

Terminated

Conditions: Metastatic Breast Cancer
HER2+ Breast Cancer

Interventions: Drug: BKM120
Drug: Trastuzumab
Drug: Capecitabine

First Posted Date: 2010-05-28

Last Posted Date: 2016-08-17

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 72

Registration Number: NCT01132664

Locations: 🇺🇸
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
🇺🇸
Sarah Cannon Research Institute Sarah Cannon Cancer Center SC, Nashville, Tennessee, United States
🇬🇧
Novartis Investigative Site, Oxford, United Kingdom

and more 5 locations

A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Bevacizumab [Avastin]
Drug: Capecitabine
Drug: Irinotecan

First Posted Date: 2010-05-26

Last Posted Date: 2015-06-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 306

Registration Number: NCT01131078

A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor

Phase 1

Completed

Conditions: Advanced Malignant Solid Tumors

Interventions: Drug: Neratinib
Drug: Capecitabine

First Posted Date: 2010-05-24

Last Posted Date: 2018-12-19

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 7

Registration Number: NCT01128842

Locations: 🇯🇵
Investigational Site, Tokyo, Japan

Epirubicin Hydrochloride, Cisplatin, and Fluorouracil or Capecitabine With or Without Lapatinib Ditosylate as First-Line Therapy in Treating Patients With Stomach Cancer or Gastroesophageal Junction Cancer

Phase 2

Terminated

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Gastric Cancer

Interventions: Drug: capecitabine
Drug: cisplatin
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: lapatinib ditosylate

First Posted Date: 2010-05-14

Last Posted Date: 2016-10-12

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 29

Registration Number: NCT01123473

Locations: 🇧🇪
Institut Jules Bordet, Brussels, Belgium
🇵🇹
I.P.O. Francisco Gentil - Centro De Lisboa, Lisboa, Portugal
🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium

and more 1 locations