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

1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Gemcitabine
Drug: Sorafenib
Drug: Placebo
Drug: Capecitabine

First Posted Date: 2007-06-28

Last Posted Date: 2014-05-20

Lead Sponsor: Accelerated Community Oncology Research Network

Target Recruit Count: 160

Registration Number: NCT00493636

Locations: 🇺🇸
Compassionate Cancer Care-Fountain Valley, Fountain Valley, California, United States
🇺🇸
Hematology Oncology Associates of New York, East Syracuse, New York, United States
🇺🇸
California Cancer Care, Greenbrae, California, United States

and more 40 locations

Capecitabine, Epirubicin, and Carboplatin in Treating Patients With Progressive, Unresectable, or Metastatic Cancer

Phase 1

Completed

Conditions: Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Gastric Cancer
Liver Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: capecitabine
Drug: carboplatin
Drug: epirubicin hydrochloride
Genetic: microarray analysis
Genetic: polymorphism analysis
Other: pharmacological study

First Posted Date: 2007-06-14

Last Posted Date: 2024-01-03

Lead Sponsor: University of Nebraska

Target Recruit Count: 46

Registration Number: NCT00486356

Locations: 🇺🇸
University of Nebraska Medical Center, Eppley Cancer Center, Omaha, Nebraska, United States

A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Bevacizumab
Drug: Capecitabine

First Posted Date: 2007-06-12

Last Posted Date: 2015-01-08

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 280

Registration Number: NCT00484939

Imatinib Mesylate, Gemcitabine, and Capecitabine in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: capecitabine
Drug: gemcitabine hydrochloride
Drug: imatinib mesylate
Genetic: mutation analysis
Genetic: nucleic acid sequencing
Genetic: polymerase chain reaction

First Posted Date: 2007-06-07

Last Posted Date: 2023-09-14

Lead Sponsor: University of Nebraska

Target Recruit Count: 13

Registration Number: NCT00483366

Locations: 🇺🇸
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States

Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer

Phase 2

Completed

Conditions: Liver Cancer

Interventions: Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin

First Posted Date: 2007-06-07

Last Posted Date: 2017-07-12

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 33

Registration Number: NCT00483405

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

A Phase II Study of Bevacizumab, Irinotecan and Capecitabine in Patients With Previously Untreated Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Bevacizumab
Drug: Irinotecan
Drug: Capecitabine

First Posted Date: 2007-06-07

Last Posted Date: 2019-02-15

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 50

Registration Number: NCT00483834

Locations: 🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada

Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer

Phase 3

Conditions: Colorectal Cancer
Metastatic Cancer

Interventions: Biological: cetuximab
Drug: capecitabine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Other: study of socioeconomic and demographic variables
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment

First Posted Date: 2007-06-05

Last Posted Date: 2013-01-23

Lead Sponsor: University of Southampton

Target Recruit Count: 340

Registration Number: NCT00482222

Locations: 🇬🇧
Addenbrooke's Hospital, Cambridge, England, United Kingdom
🇬🇧
St. Mary's Hospital, Newport, England, United Kingdom
🇬🇧
Royal Marsden - London, London, England, United Kingdom

and more 19 locations