Capecitabine

Generic Name
Capecitabine
Brand Names
Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva
Drug Type
Small Molecule
Chemical Formula
C15H22FN3O6
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

A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma

Phase 1
Completed
Conditions
Interventions
First Posted Date
2006-12-15
Last Posted Date
2015-03-27
Lead Sponsor
Yale University
Target Recruit Count
25
Registration Number
NCT00411762
Locations
🇺🇸

Yale Comprehensive Cancer Center at Yale University School of Medicine, New Haven, Connecticut, United States

Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-12-13
Last Posted Date
2013-02-20
Lead Sponsor
Sanofi
Target Recruit Count
1035
Registration Number
NCT00411229
Locations
🇨🇳

Sanofi-Aventis, Taipei, Taiwan

Oxaliplatin, Capecitabine, and Bevacizumab Followed By Surgery and/or Radiofrequency Ablation in Patients With Colorectal Cancer

First Posted Date
2006-12-07
Last Posted Date
2017-06-09
Lead Sponsor
University of California, Davis
Registration Number
NCT00408772
Locations
🇺🇸

University of California Davis Cancer Center, Sacramento, California, United States

Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery

First Posted Date
2006-12-07
Last Posted Date
2017-09-18
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
1206
Registration Number
NCT00408408
Locations
🇺🇸

Iredell Memorial Hospital, Statesville, North Carolina, United States

🇺🇸

Hattiesburg Clinic, PA at Forrest General, Hattiesburg, Mississippi, United States

🇺🇸

Cancer Care Center, Incorporated, Salem, Ohio, United States

and more 435 locations

Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

First Posted Date
2006-12-07
Last Posted Date
2018-07-23
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
39
Registration Number
NCT00408564
Locations
🇺🇸

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2006-11-23
Last Posted Date
2016-01-14
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
36
Registration Number
NCT00403429
Locations
🇮🇹

Clinica Malzoni, Reparto di Ginecologia Oncologica, Avellino, AV, Italy

🇮🇹

Ospedale Ramazzini, Day Hospital Oncologico, Carpi, MO, Italy

🇮🇹

IRCCS Oncologico Bari, Oncologia Medica, Bari, BA, Italy

and more 14 locations

Placebo-Controlled Study of Perifosine + Single Agent Chemotherapy for Metastatic Cancer Patients

First Posted Date
2006-11-14
Last Posted Date
2018-03-14
Lead Sponsor
AEterna Zentaris
Target Recruit Count
381
Registration Number
NCT00398879
Locations
🇺🇸

AOI Pharmaceuticals Investigative Site, Appleton, Wisconsin, United States

Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors

First Posted Date
2006-11-10
Last Posted Date
2017-03-01
Lead Sponsor
Pamela L. Kunz
Target Recruit Count
40
Registration Number
NCT00398320
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer

Phase 2
Withdrawn
Conditions
First Posted Date
2006-11-09
Last Posted Date
2021-02-17
Lead Sponsor
Medstar Health Research Institute
Registration Number
NCT00397761
Locations
🇺🇸

Washington Cancer Institute at Washington Hospital Center, Washington, District of Columbia, United States

Oxaliplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients Undergoing Surgery for High-Risk Rectal Cancer

Phase 2
Conditions
First Posted Date
2006-10-03
Last Posted Date
2010-01-13
Lead Sponsor
Royal Marsden NHS Foundation Trust
Target Recruit Count
164
Registration Number
NCT00383695
Locations
🇬🇧

Dorset Cancer Centre, Poole Dorset, England, United Kingdom

🇪🇸

Hospital Universitario La Paz, Madrid, Spain

🇸🇪

Karolinska University Hospital - Solna, Stockholm, Sweden

and more 10 locations
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