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

Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Phase 3

Conditions: Advanced Gastric Cancer

Interventions: Drug: Paclitaxel
Drug: capecitabine
Drug: cisplatin

First Posted Date: 2009-11-18

Last Posted Date: 2015-05-19

Lead Sponsor: Peking University

Target Recruit Count: 320

Registration Number: NCT01015339

Locations: 🇨🇳
Department of GI Oncology, Peking University, School of Oncology, Beijing, Beijing, China

Lapatinib in Combination With Vinorelbine

Phase 2

Completed

Conditions: Cancer

Interventions: Drug: Lapatinib
Drug: Vinorelbine
Drug: Capecitabine

First Posted Date: 2009-11-16

Last Posted Date: 2017-05-31

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 112

Registration Number: NCT01013740

Locations: 🇪🇸
Novartis Investigative Site, Zamora, Spain

Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

Phase 3

Active, not recruiting

Conditions: Pancreatic Adenocarcinoma
Stage II Pancreatic Cancer AJCC v6 and v7
Pancreatic Ductal Adenocarcinoma
Stage I Pancreatic Cancer AJCC v6 and v7
Pancreatic Intraductal Papillary-Mucinous Neoplasm

Interventions: Procedure: Biospecimen Collection
Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Chemotherapy
Drug: Erlotinib Hydrochloride
Procedure: Computed Tomography
Drug: Capecitabine
Drug: Gemcitabine Hydrochloride
Procedure: Magnetic Resonance Imaging
Other: Quality-of-Life Assessment
Drug: Fluorouracil
Procedure: X-Ray Imaging
Radiation: Intensity-Modulated Radiation Therapy

First Posted Date: 2009-11-16

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 546

Registration Number: NCT01013649

Locations: 🇺🇸
Adena Regional Medical Center, Chillicothe, Ohio, United States
🇺🇸
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States
🇺🇸
Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States

and more 688 locations

Oxaliplatin and S-1 or Oxaliplatin and Capecitabine in Treating Patients With Recurrent, Metastatic, or Unresectable Gastric Cancer

Phase 2

Conditions: Gastric Cancer

Interventions: Drug: oxaliplatin
Drug: capecitabine
Drug: tegafur-gimeracil-oteracil potassium

First Posted Date: 2009-09-28

Last Posted Date: 2011-10-20

Lead Sponsor: Yonsei University

Target Recruit Count: 130

Registration Number: NCT00985556

Locations: 🇰🇷
Yonsei Cancer Center at Yonsei University Medical Center, Seoul, Korea, Republic of

Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer

Phase 1

Completed

Conditions: Pancreatic Cancer
Periampullary Adenocarcinoma

Interventions: Drug: capecitabine
Drug: vorinostat
Radiation: Radiotherapy
Procedure: Surgery to remove tumor

First Posted Date: 2009-09-24

Last Posted Date: 2015-06-15

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 21

Registration Number: NCT00983268

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Radiation: WBRT
Drug: Standard of Care
Drug: Capecitabine

First Posted Date: 2009-09-15

Last Posted Date: 2016-11-15

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 24

Registration Number: NCT00977379

Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Phase 1

Completed

Conditions: Rectal Cancer

First Posted Date: 2009-09-09

Last Posted Date: 2017-10-25

Lead Sponsor: University College, London

Target Recruit Count: 82

Registration Number: NCT00972881

Locations: 🇬🇧
Cancer Research UK and University College London Cancer Trials Centre, Rhyl, Denbighshire, Wales, United Kingdom
🇬🇧
Yorkshire Regional Clinical Trials & Research Unit, Leeds, England, United Kingdom
🇬🇧
Christie Hospital, Manchester, England, United Kingdom

and more 2 locations

Capecitabine, Panitumumab, and Radiation Therapy With or Without Irinotecan Hydrochloride in Treating Patients Undergoing Surgery for Localized Rectal Cancer

Phase 2

Conditions: Colorectal Cancer

First Posted Date: 2009-08-28

Last Posted Date: 2014-01-10

Lead Sponsor: Loma Linda Oncology Medical Group, Inc.

Target Recruit Count: 54

Registration Number: NCT00967655

Locations: 🇺🇸
New Hope Cancer and Research Institute - Pomona, Redlands, California, United States
🇺🇸
New Hope Cancer and Research Institute - Glendora, Redlands, California, United States
🇺🇸
Davood Vafai, MD, Medical Offices, Incorporated, Redlands, California, United States

and more 1 locations