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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

Dose Escalation Study of Lithium With Oxaliplatin and Capecitabine in Advanced Oesophago-Gastric or Colorectal Cancer

Phase 1
Active, not recruiting
Conditions
Colorectal Neoplasms
Stomach Neoplasm
Esophageal Neoplasms
Interventions
First Posted Date
2017-05-15
Last Posted Date
2023-10-13
Lead Sponsor
Cancer Trials Ireland
Target Recruit Count
2
Registration Number
NCT03153280
Locations
🇮🇪

St James's Hospital, Dublin 8, Ireland

🇮🇪

Cork University Hospital, Cork, Ireland

Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Interventions
First Posted Date
2017-05-09
Last Posted Date
2017-05-09
Lead Sponsor
The University of Hong Kong
Target Recruit Count
32
Registration Number
NCT03146377
Locations
🇭🇰

Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong

QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

Phase 1
Terminated
Conditions
Pancreatic Cancer
Interventions
Drug: Cyclophosphamide
Drug: Oxaliplatin
Drug: Capecitabine
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: nab-paclitaxel
Biological: bevacizumab
Biological: avelumab
Biological: ALT-803
Biological: aNK for Infusion
Biological: ETBX-011
Biological: GI-4000
First Posted Date
2017-05-02
Last Posted Date
2024-06-11
Lead Sponsor
ImmunityBio, Inc.
Target Recruit Count
3
Registration Number
NCT03136406
Locations
🇺🇸

Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States

Study of Varlitinib Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer

Phase 2
Withdrawn
Conditions
Advanced or Metastatic Biliary Tract Cancer
Interventions
First Posted Date
2017-04-26
Last Posted Date
2018-05-23
Lead Sponsor
ASLAN Pharmaceuticals
Registration Number
NCT03129074

Capecitabine and Y-90 Radioembolization in Treating Patients With Advanced Bile Duct Cancer in the Liver That Cannot Be Removed by Surgery

Phase 1
Withdrawn
Conditions
Stage IVA Intrahepatic Cholangiocarcinoma
Stage IVB Intrahepatic Cholangiocarcinoma
Bile Duct Adenocarcinoma
Stage III Intrahepatic Cholangiocarcinoma
Interventions
Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Radiation: Radioembolization
First Posted Date
2017-04-18
Last Posted Date
2017-04-18
Lead Sponsor
City of Hope Medical Center
Registration Number
NCT03117855
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels

Phase 2
Terminated
Conditions
Metastatic Colorectal Cancer
Interventions
Drug: FOLFOXIRI
Drug: FOLFOX
Drug: FOLFIRI
Drug: LV5FU2
Drug: Bevacizumab
Drug: Capecitabine
First Posted Date
2017-04-18
Last Posted Date
2024-12-24
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Target Recruit Count
54
Registration Number
NCT03117972
Locations
🇫🇷

CHU de REIMS, Hôpital Robert Debré, Reims, France

🇫🇷

Centre Hospitalier Universitaire de Besançon, Besançon, France

🇫🇷

Centre Hospitalier de Boulogne sur Mer, Boulogne-sur-Mer, France

and more 7 locations

Apatinib Combined With Capecitabine Compared With Apatinib Treat Advanced Hepatocellular Carcinoma

Phase 2
Conditions
Hepatocellular Carcinoma
Interventions
First Posted Date
2017-04-14
Last Posted Date
2017-05-15
Lead Sponsor
First Affiliated Hospital of Guangxi Medical University
Target Recruit Count
170
Registration Number
NCT03114085

Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in People With Advanced Biliary Tract Carcinoma (BTC)

Phase 2
Completed
Conditions
Liver Cancer
Biliary Tract Neoplasms
Cholangiocarcinoma
Bile Duct Cancer
Gallbladder Cancer
Interventions
Biological: Pembrolizumab (MK-3475)
Drug: Oxaliplatin
Drug: Capecitabine
First Posted Date
2017-04-13
Last Posted Date
2021-12-03
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
11
Registration Number
NCT03111732
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer

Phase 2
Completed
Conditions
Biliary Tract Cancer
Interventions
Drug: Capecitabine
Drug: Varlitinib
Drug: Placebo (for Varlitinib)
First Posted Date
2017-03-28
Last Posted Date
2021-08-03
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
151
Registration Number
NCT03093870
Locations
🇺🇸

Karmanos Cancer Institute/Wayne State University, Detroit, Michigan, United States

🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

🇯🇵

There are 7 sites in different cities in Japan, Chiba, Japan

and more 18 locations

Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
Biological: Trastuzumab Emtansine
Drug: Lapatinib
Drug: Capecitabine
First Posted Date
2017-03-21
Last Posted Date
2023-05-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
351
Registration Number
NCT03084939
Locations
🇨🇳

Beijing Hospital, Beijing City, China

🇨🇳

Beijing Cancer Hospital, Beijing, China

🇨🇳

Changzhou First People's Hospital, Changzhou, China

and more 15 locations
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