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

Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery

Phase 3

Active, not recruiting

Conditions: Breast Cancer

Interventions: Biological: pegfilgrastim
Drug: capecitabine
Drug: cyclophosphamide
Drug: epirubicin hydrochloride
Procedure: adjuvant therapy
Drug: fluorouracil
Drug: methotrexate

First Posted Date: 2006-03-13

Last Posted Date: 2018-08-08

Lead Sponsor: Institute of Cancer Research, United Kingdom

Target Recruit Count: 4400

Registration Number: NCT00301925

Locations: 🇬🇧
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom
🇬🇧
Sussex Cancer Centre at Royal Sussex County Hospital, Brighton, England, United Kingdom
🇬🇧
Burnley General Hospital, Burnley, England, United Kingdom

and more 147 locations

Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

Phase 2

Completed

Conditions: Rectal Cancer

Interventions: Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2006-02-28

Last Posted Date: 2013-12-31

Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group

Target Recruit Count: 60

Registration Number: NCT00297141

Locations: 🇦🇹
Hospital BHB St. Veit/Glan, Surgery, St. Veit a. d. Glan, Carinthia, Austria
🇦🇹
Paracelsus Medical University Salzburg - Oncology, Salzburg, Austria
🇦🇹
Medical University of Graz, Oncology, Graz, Styria, Austria

and more 5 locations

Preoperative Chemoradiation With Capecitabine and Cetuximab

Phase 2

Completed

Conditions: Rectal Cancer

Interventions: Drug: Capecitabine
Drug: Cetuximab

First Posted Date: 2006-02-28

Last Posted Date: 2011-12-30

Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group

Target Recruit Count: 31

Registration Number: NCT00297128

Locations: 🇦🇹
Medical University of Graz, Oncology, Graz, Styria, Austria
🇦🇹
Hospital Wiener Neustadt, Surgery, Wiener Neustadt, Lower Austria, Austria
🇦🇹
Hospital BHB St. Veit/Glan, Surgery, St. Veit a. d. Glan, Carinthia, Austria

and more 7 locations

Dose Dense Therapy and Bevacizumab in Solid Tumors and Colorectal Cancer

Phase 1

Terminated

Conditions: Colorectal Cancer
Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2006-02-24

Last Posted Date: 2012-01-16

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 12

Registration Number: NCT00296062

Locations: 🇺🇸
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Neoplasms

Interventions: Drug: Capecitabine
Drug: 131I-huA33 (131-Iodine on humanised monoclonal antibody A33)

First Posted Date: 2006-02-14

Last Posted Date: 2022-10-10

Lead Sponsor: Ludwig Institute for Cancer Research

Target Recruit Count: 19

Registration Number: NCT00291486

Locations: 🇦🇺
Ludwig Institute Oncology Unit and Tumor Targeting Program, Austin Health, Heidelberg, Victoria, Australia

Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin

First Posted Date: 2006-02-13

Last Posted Date: 2013-05-07

Lead Sponsor: Herbert Hurwitz

Target Recruit Count: 30

Registration Number: NCT00290615

Locations: 🇺🇸
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Capecitabine
Drug: Docetaxel

First Posted Date: 2006-02-13

Last Posted Date: 2017-12-02

Lead Sponsor: University of Miami

Target Recruit Count: 45

Registration Number: NCT00290693

Locations: 🇺🇸
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center, Miami Beach, Florida, United States