MedPath

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

Detect V / CHEVENDO (Chemo vs. Endo)

First Posted Date
2015-01-26
Last Posted Date
2024-06-04
Lead Sponsor
Prof. Wolfgang Janni
Target Recruit Count
271
Registration Number
NCT02344472
Locations
🇩🇪

University Hospital Ulm Gynecology/Obstetrics, Ulm, Germany

Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2015-01-14
Last Posted Date
2017-10-17
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
200
Registration Number
NCT02338245
Locations
🇵🇭

Philippines, Dasmarinas, Philippines

🇸🇬

Singapore, Singapore, Singapore

🇦🇺

Australia, Western Australia, Australia

and more 4 locations

A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)

Phase 2
Completed
Conditions
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Interventions
First Posted Date
2015-01-09
Last Posted Date
2022-08-08
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
318
Registration Number
NCT02335411

Low-dose Capecitabine Adjuvant Chemotherapy for Elderly Patients With Stage II/III Colorectal Cancer

Phase 3
Conditions
Colorectal Neoplasms
Interventions
First Posted Date
2014-12-15
Last Posted Date
2016-09-13
Lead Sponsor
West China Hospital
Target Recruit Count
710
Registration Number
NCT02316535
Locations
🇨🇳

West China Hospital, Chengdu, Sichuan, China

A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

Phase 3
Completed
Conditions
Gastroesophageal Junction Adenocarcinoma
Metastatic Gastric Adenocarcinoma
Interventions
First Posted Date
2014-12-10
Last Posted Date
2021-08-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
645
Registration Number
NCT02314117
Locations
🇺🇸

UT Southwestern Med Ctr, Dallas, Texas, United States

🇺🇸

Comprehensive Blood and Cancer Center, Bakersfield, California, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

and more 28 locations

Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)

Phase 2
Completed
Conditions
Pancreatic Neoplasms
Interventions
Drug: nab-Paclitaxel
Drug: Gemcitabine
Drug: Chemoradiation
Drug: Capecitabine
Procedure: Surgery
First Posted Date
2014-11-25
Last Posted Date
2019-03-20
Lead Sponsor
Celgene
Target Recruit Count
107
Registration Number
NCT02301143
Locations
🇺🇸

University of Massachusetts, Worcester, Massachusetts, United States

🇺🇸

Mark H Zangmeister Center, Columbus, Ohio, United States

🇺🇸

Tufts - New England Medical Center, Boston, Massachusetts, United States

and more 39 locations

Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics

Phase 1
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2014-11-21
Last Posted Date
2018-10-15
Lead Sponsor
NYU Langone Health
Target Recruit Count
44
Registration Number
NCT02297230
Locations
🇺🇸

Weill Medical College of Cornell University, New York, New York, United States

Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer

Phase 2
Terminated
Conditions
Cancer
Interventions
First Posted Date
2014-11-19
Last Posted Date
2019-07-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
62
Registration Number
NCT02294786
Locations
🇬🇧

Novartis Investigative Site, Romford, United Kingdom

A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

Phase 2
Completed
Conditions
Colorectal Cancer
Interventions
Drug: FOLFOX induction regimen
Drug: Fluoropyrimidine (5-FU/LV or capecitabine)
Drug: Cetuximab
Drug: Trastuzumab
Drug: Bevacizumab
Drug: Pertuzumab
Drug: Vemurafenib
Drug: Atezolizumab
Drug: Cobimetinib
Drug: 5-FU/LV
Drug: Capecitabine
First Posted Date
2014-11-14
Last Posted Date
2024-05-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1044
Registration Number
NCT02291289
Locations
🇦🇷

Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología, Buenos Aires, Argentina

🇧🇪

Institut Jules Bordet X, Brussels, Belgium

🇧🇪

Hospital Erasme, Bruxelles, Belgium

and more 151 locations

Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer

Phase 3
Conditions
Stomach Neoplasms
Interventions
First Posted Date
2014-11-13
Last Posted Date
2017-06-14
Lead Sponsor
The Catholic University of Korea
Target Recruit Count
184
Registration Number
NCT02289547
Locations
🇰🇷

St. Mary's Hospital, Seoul, Korea, Republic of

🇰🇷

Incheon St. Mary's Hospital, Incheon, Korea, Republic of

🇰🇷

St. Vincent's Hospital, Suwon, Gyeonggi-do, Korea, Republic of

and more 5 locations
© Copyright 2025. All Rights Reserved by MedPath