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

A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer

Phase 2

Completed

Conditions: Gastric Cancer

First Posted Date: 2012-01-25

Last Posted Date: 2013-06-26

Lead Sponsor: Jeroen Bosch Ziekenhuis

Target Recruit Count: 50

Registration Number: NCT01517009

Locations: 🇳🇱
VieCuri Hospital, Venlo, Limburg, Netherlands
🇳🇱
Jeroen Bosch Hospital, Den Bosch, Noord-Brabant, Netherlands
🇳🇱
Elkerliek Hospital, Helmond, Noord Brabant, Netherlands

and more 2 locations

An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Bevacizumab
Drug: Capecitabine/Oxaliplatin
Drug: Fluorouracil/Folinic Acid/Oxaliplatin
Drug: Fluorouracil/Folinic Acid/Irinotecan
Drug: Fluorouracil +/- Folinic Acid
Drug: Capecitabine

First Posted Date: 2012-01-09

Last Posted Date: 2018-05-14

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 719

Registration Number: NCT01506167

Locations: 🇬🇧
Walsall Manor Hospital, Walsall, United Kingdom
🇬🇧
University Hospital of North Staffordhire, Blackpool, United Kingdom
🇬🇧
Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre, Bath, United Kingdom

and more 39 locations

Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive

Phase 2

Completed

Conditions: Stage IV Gastric Cancer With Metastasis

Interventions: Drug: Trastuzumab
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2012-01-04

Last Posted Date: 2015-08-27

Lead Sponsor: Fundación para el Progreso de la Oncología en Cantabria

Target Recruit Count: 45

Registration Number: NCT01503983

Locations: 🇪🇸
Hospital de Basurto, Bilbao, Spain
🇪🇸
Hospital Arnau de Vilanova de LLeida, Lleida, Spain
🇪🇸
Hospital Xeral Cies, Vigo, Spain

and more 10 locations

Capecitabine in the Perioperative Treatment of Rectal Cancer

Phase 3

Completed

Conditions: Rectal Cancer

Interventions: Drug: 5-FU
Drug: Capecitabine

First Posted Date: 2011-12-29

Last Posted Date: 2020-11-27

Lead Sponsor: Universitätsmedizin Mannheim

Target Recruit Count: 401

Registration Number: NCT01500993

Locations: 🇩🇪
Dr Hans Walter Lindemann, Hagen, Germany
🇩🇪
Dr Elisabeth Fritz, Koblenz, Germany
🇩🇪
Prof Hartmut Link, Kaiserslautern, Germany

and more 11 locations

Dovitinib Lactate, Gemcitabine Hydrochloride, and Capecitabine in Treating Patients With Advanced or Metastatic Solid Tumors, Pancreatic Cancer and Biliary Cancers

Phase 1

Completed

Conditions: Adenocarcinoma of the Pancreas
Stage III Pancreatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Stage IV Pancreatic Cancer

Interventions: Drug: dovitinib lactate
Drug: gemcitabine hydrochloride
Drug: capecitabine
Other: laboratory biomarker analysis
Other: enzyme-linked immunosorbent assay
Other: pharmacological study

First Posted Date: 2011-12-22

Last Posted Date: 2022-07-22

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 26

Registration Number: NCT01497392

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: HKI-272
Procedure: Surgical Resection
Drug: Capecitabine
Drug: Ado-Trastuzumab Emtansine

First Posted Date: 2011-12-19

Last Posted Date: 2024-05-22

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 140

Registration Number: NCT01494662

Locations: 🇺🇸
University of North Carolina at Chapel Hill - Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
UPMC Passavant Cranberry, Cranberry Township, Pennsylvania, United States

and more 15 locations

Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

Phase 2

Conditions: Pancreatic Cancer

Interventions: Drug: Capecitabine
Drug: Hydroxychloroquine
Radiation: Proton or Photon Radiation Therapy

First Posted Date: 2011-12-16

Last Posted Date: 2021-02-02

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 50

Registration Number: NCT01494155

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

Phase 1

Conditions: Rectal Cancer

Interventions: Drug: Irinotecan
Drug: Capecitabine
Radiation: Radiotherapy

First Posted Date: 2011-11-18

Last Posted Date: 2011-11-18

Lead Sponsor: Fudan University

Target Recruit Count: 60

Registration Number: NCT01474187

Locations: 🇨🇳
Cancer Hospital, Fudan University, Shanghai, Shanghai, China

Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction

Phase 3

Conditions: Gastric Cancer

Interventions: Drug: capecitabine

First Posted Date: 2011-11-09

Last Posted Date: 2011-11-10

Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Target Recruit Count: 300

Registration Number: NCT01468389

Locations: 🇨🇳
307 Hospital of PLA, Beijing, Beijing, China

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

Phase 2

Completed

Conditions: Gastric Cancer

Interventions: Drug: Capecitabine
Drug: Cisplatin
Drug: Pertuzumab
Drug: Trastuzumab

First Posted Date: 2011-10-27

Last Posted Date: 2018-08-09

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 30

Registration Number: NCT01461057

Locations: 🇨🇿
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, Czechia
🇧🇪
UZ Leuven Gasthuisberg, Leuven, Belgium
🇮🇹
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy

and more 21 locations

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