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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

A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours

Phase 1
Completed
Conditions
Advanced or Metastatic Biliary Tract Cancer
Advanced or Metastatic Solid Tumors
Interventions
First Posted Date
2017-03-17
Last Posted Date
2018-06-28
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT03082053
Locations
🇯🇵

ASLAN Selected sites, Tokyo, Japan

Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Phase 2
Completed
Conditions
Biliary Tract Cancer
Adjuvant Chemotherapy
Capecitabine
Gemcitabine
Cholangiocarcinoma
Cisplatin
Interventions
First Posted Date
2017-03-14
Last Posted Date
2022-12-06
Lead Sponsor
Asan Medical Center
Target Recruit Count
101
Registration Number
NCT03079427
Locations
🇰🇷

Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of

Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer

Phase 2
Recruiting
Conditions
Stage III Pancreatic Cancer AJCC v6 and v7
Pancreatic Adenocarcinoma
Stage IB Pancreatic Cancer AJCC v6 and v7
Stage IIA Pancreatic Cancer AJCC v6 and v7
Recurrent Pancreatic Carcinoma
Stage I Pancreatic Cancer AJCC v6 and v7
Stage IA Pancreatic Cancer AJCC v6 and v7
Stage IV Pancreatic Cancer AJCC v6 and v7
Stage II Pancreatic Cancer AJCC v6 and v7
Stage IIB Pancreatic Cancer AJCC v6 and v7
Interventions
Drug: Capecitabine
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Radiation: Stereotactic Body Radiation Therapy
Drug: Zoledronic Acid
First Posted Date
2017-03-08
Last Posted Date
2024-01-05
Lead Sponsor
University of Nebraska
Target Recruit Count
44
Registration Number
NCT03073785
Locations
🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in People With Previously Untreated Metastatic Colorectal Cancer QUILT-2.004

Phase 2
Terminated
Conditions
Colorectal Tumors
Colorectal Neoplasms
Colorectal Cancer
Colorectal Carcinoma
Colorectal Adenocarcinoma
Interventions
First Posted Date
2017-02-13
Last Posted Date
2021-12-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
30
Registration Number
NCT03050814
Locations
🇺🇸

Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

🇺🇸

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

Pembrolizumab and Capecitabine in Treating Patients With Locally Advanced or Metastatic Triple Negative or Hormone-Refractory Breast Cancer That Cannot Be Removed by Surgery

Phase 2
Conditions
Stage IIIB Breast Cancer
Estrogen Receptor Negative
HER2/Neu Negative
Stage III Breast Cancer
Triple-Negative Breast Carcinoma
Progesterone Receptor Negative
Recurrent Breast Carcinoma
Stage IIIA Breast Cancer
Stage IV Breast Cancer
Stage IIIC Breast Cancer
Interventions
Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
First Posted Date
2017-02-07
Last Posted Date
2020-07-13
Lead Sponsor
Northwestern University
Target Recruit Count
30
Registration Number
NCT03044730
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

Northwestern Lake Forest Hospital, Lake Forest, Illinois, United States

Multicenter, Prospective, RCT:Investigation of Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.

Not Applicable
Conditions
Rectal Cancer, Adenocarcinoma
Neoadjuvant Chemoradiation
Interventions
Other: non-NCRT
Other: NCRT
Procedure: TEM
Procedure: radical resection
Drug: capecitabine with oxaliplatin
Drug: capecitabine
First Posted Date
2017-02-03
Last Posted Date
2017-02-03
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
1200
Registration Number
NCT03042000

A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

Phase 2
Terminated
Conditions
Liver Cancer
Hepatocellular Cancer
Interventions
First Posted Date
2017-01-20
Last Posted Date
2017-04-13
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
4
Registration Number
NCT03026803
Locations
🇺🇸

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

Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer

Phase 3
Recruiting
Conditions
Breast Neoplasm Female
Interventions
Procedure: Neo-adjuvant Chemotherapy
Drug: Capecitabine
First Posted Date
2017-01-05
Last Posted Date
2017-01-10
Lead Sponsor
The First Hospital of Jilin University
Target Recruit Count
1588
Registration Number
NCT03011060
Locations
🇨🇳

the First Hospital of Jilin University, Changchun, Jilin, China

Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer

First Posted Date
2017-01-04
Last Posted Date
2024-11-25
Lead Sponsor
Immodulon Therapeutics Ltd
Target Recruit Count
2
Registration Number
NCT03009058
Locations
🇫🇷

Centre Léon Bérard, Dpt Medecine & INSERM, Lyon, France

🇫🇷

Gustave Roussy Cancer Center, Villejuif, France

🇬🇧

St George's University of London, Institute of Infection and Immunity, London, United Kingdom

and more 1 locations

Study of Adjuvant ONO-4538 With Resected Gastric Cancer

Phase 3
Completed
Conditions
Gastric Cancer
Interventions
First Posted Date
2016-12-30
Last Posted Date
2024-05-03
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Target Recruit Count
800
Registration Number
NCT03006705
Locations
🇨🇳

Anhui Province Clinical Site, Anhui Province, China

🇨🇳

Zhejiang Province Clinical Site, Zhejiang Province, China

🇯🇵

Nagano Clinical Site, Saku, Nagano, Japan

and more 89 locations
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