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 Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

Phase 3

Completed

Conditions: Gastric Cancer

Interventions: Drug: 5-Fluorouracil
Drug: Capecitabine
Drug: Cisplatin
Drug: Placebo
Drug: Pertuzumab
Drug: Trastuzumab

First Posted Date: 2013-01-24

Last Posted Date: 2020-12-30

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 780

Registration Number: NCT01774786

Locations: 🇺🇸
Florida Cancer Specialists - SCRI; Pharmacy, Fort Myers, Florida, United States
🇺🇸
Weill Medical College of Cornell University; Division of Hematology & Medical Oncology, New York, New York, United States
🇺🇸
University Of Chicago Medical Center; Section Of Hematology/Oncology, Chicago, Illinois, United States

and more 169 locations

Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Neoplasms

Interventions: Drug: 5-fluorouracil
Drug: bevacizumab
Drug: capecitabine
Drug: irinotecan
Drug: folinic acid
Drug: oxaliplatin

First Posted Date: 2013-01-10

Last Posted Date: 2017-09-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 280

Registration Number: NCT01765582

Locations: 🇺🇸
USC Norris Cancer Center, Los Angeles, California, United States
🇺🇸
Johns Hopkins Univ; Bunting Blaustein Cancer Center, Baltimore, Maryland, United States
🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States

and more 42 locations

Chemoradiotherapy for Patients With Oligometastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Cancer
Metastases

Interventions: Drug: Capecitabine
Drug: Bevacizumab
Radiation: Radiotherapy

First Posted Date: 2013-01-03

Last Posted Date: 2022-07-01

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Target Recruit Count: 1

Registration Number: NCT01759238

Locations: 🇩🇪
University Hospital Hamburg-Eppendorf, Hamburg, Germany

GTX-RT in Borderline Resectable Pancreatic Cancer

Phase 2

Terminated

Conditions: Pancreatic Cancer

Interventions: Drug: Capecitabine
Drug: Gemcitabine
Drug: Docetaxel
Radiation: Stereotactic body radiation therapy (SBRT)
Other: Restaging review after radiation
Procedure: Surgery
Drug: 5-Fluorouracil

First Posted Date: 2012-12-21

Last Posted Date: 2015-08-13

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 9

Registration Number: NCT01754623

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer

Phase 2

Completed

Conditions: Gastric Cancer
Gastroesophageal Junction Cancer

Interventions: Drug: Oxaliplatin
Radiation: Radiation
Drug: Capecitabine
Drug: Trastuzumab

First Posted Date: 2012-12-13

Last Posted Date: 2019-10-09

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 34

Registration Number: NCT01748773

Locations: 🇹🇷
Marmara Uni Faculty of Medicine; Medical Oncology, Istanbul, Turkey
🇹🇷
Baskent University Medical Faculty; Internal Medicine, Ankara, Turkey
🇹🇷
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, Turkey

and more 6 locations

A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma

Phase 1

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: cisplatin
Drug: nab-paclitaxel
Drug: capecitabine
Drug: gemcitabine

First Posted Date: 2012-11-21

Last Posted Date: 2017-09-01

Lead Sponsor: IRCCS San Raffaele

Target Recruit Count: 137

Registration Number: NCT01730222

Locations: 🇮🇹
IRCCS S Raffaele, Milan, Italy

A Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Recurrent Colon Carcinoma
Recurrent Rectal Carcinoma

Interventions: Drug: Capecitabine
Drug: Celecoxib
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Radiation: Stereotactic Radiosurgery
Procedure: Therapeutic Conventional Surgery