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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

Neoadjuvant Treatment of Colon Cancer

Phase 2
Completed
Conditions
Colon Cancer
Interventions
First Posted Date
2010-04-21
Last Posted Date
2015-05-21
Lead Sponsor
Vejle Hospital
Target Recruit Count
76
Registration Number
NCT01108107
Locations
🇩🇰

Dept. of Oncology, Hilleroed Hospital, Hilleroed, Denmark

🇩🇰

Department of Oncology, Vejle Hospital, Vejle, Denmark

🇩🇰

Department of Oncology, Herlev Hospital, Herlev, Denmark

A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Phase 1
Completed
Conditions
Metastatic Gastric Cancer
Interventions
First Posted Date
2010-04-07
Last Posted Date
2015-12-29
Lead Sponsor
Samsung Medical Center
Target Recruit Count
59
Registration Number
NCT01099527
Locations
🇰🇷

Samsung Cancer Center, Seoul, Korea, Republic of

Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

Phase 3
Completed
Conditions
Colorectal Cancer
Interventions
First Posted Date
2010-04-01
Last Posted Date
2013-07-02
Lead Sponsor
AEterna Zentaris
Target Recruit Count
468
Registration Number
NCT01097018
Locations
🇺🇸

Yale University School of Medicine, New Haven, Connecticut, United States

🇺🇸

TN Oncology, Nashville, Tennessee, United States

Study of Micrometastases in Patients With Stage I or Stage II Localized Colon Cancer That Can Be Removed by Surgery

Phase 2
Conditions
Colorectal Cancer
First Posted Date
2010-04-01
Last Posted Date
2013-08-12
Lead Sponsor
Jeroen Bosch Ziekenhuis
Target Recruit Count
1500
Registration Number
NCT01097265
Locations
🇳🇱

Catharina Ziekenhuis, Eindhoven, Netherlands

🇳🇱

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands

🇳🇱

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands

and more 8 locations

Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-03-29
Last Posted Date
2022-04-28
Lead Sponsor
Pierre Fabre Medicament
Target Recruit Count
770
Registration Number
NCT01095003

Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer

Phase 3
Active, not recruiting
Conditions
Borderline Ovarian Mucinous Tumor
Stage IA Ovarian Cancer AJCC v6 and v7
Recurrent Fallopian Tube Carcinoma
Stage IIA Fallopian Tube Cancer AJCC v6 and v7
Stage IIB Ovarian Cancer AJCC v6 and v7
Stage IIIB Fallopian Tube Cancer AJCC v7
Stage IIIC Ovarian Cancer AJCC v6 and v7
Ovarian Mucinous Cystadenocarcinoma
Recurrent Ovarian Carcinoma
Stage IC Fallopian Tube Cancer AJCC v6 and v7
Interventions
Drug: Carboplatin
Drug: Capecitabine
Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Drug: Oxaliplatin
Other: Quality-of-Life Assessment
First Posted Date
2010-03-05
Last Posted Date
2024-12-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
50
Registration Number
NCT01081262
Locations
🇺🇸

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

🇺🇸

University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States

🇺🇸

Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

and more 245 locations

Everolimus and Capecitabine in Patients With Advanced Malignancy

Phase 1
Conditions
Advanced Malignancies
First Posted Date
2010-03-03
Last Posted Date
2010-03-03
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
35
Registration Number
NCT01079702
Locations
🇳🇱

Academic Medical Center, Amsterdam, Netherlands

Everolimus, Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer

Phase 1
Completed
Conditions
Metastatic Pancreatic Cancer
First Posted Date
2010-03-02
Last Posted Date
2021-04-21
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
35
Registration Number
NCT01077986
Locations
🇳🇱

Academic Medical Center, Amsterdam, Netherlands

Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

Phase 2
Terminated
Conditions
Triple Negative Metastatic Breast Cancer
Interventions
First Posted Date
2010-02-17
Last Posted Date
2016-03-17
Lead Sponsor
ARCAGY/ GINECO GROUP
Target Recruit Count
64
Registration Number
NCT01069796
Locations
🇫🇷

Centre Paul Papin, Angers, France

🇫🇷

Hôpital Privé Clairval, Marseille, France

🇫🇷

Centre Hospitalier Bretagne Atlantique, Vannes, France

and more 14 locations

A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

Phase 2
Conditions
Rectal Cancer
Interventions
Drug: Oxaliplatin
Drug: Capecitabine
Radiation: Radiotherapy
Procedure: Surgery
First Posted Date
2010-02-09
Last Posted Date
2012-03-14
Lead Sponsor
Fudan University
Target Recruit Count
240
Registration Number
NCT01064999
Locations
🇨🇳

Cancer Hospital, Fudan University, Shanghai, Shanghai, China

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