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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

Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

Phase 2
Active, not recruiting
Conditions
Metastatic Breast Cancer
Leptomeningeal Disease
Interventions
First Posted Date
2018-04-18
Last Posted Date
2024-01-11
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
17
Registration Number
NCT03501979
Locations
🇺🇸

University of Michigan-, Ann Arbor, Michigan, United States

🇺🇸

UCSF-Mission Bay, San Francisco, California, United States

🇺🇸

University of Chicago, Chicago, Illinois, United States

and more 6 locations

OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual Disease

Phase 2
Completed
Conditions
Triple Negative Breast Cancer
Interventions
First Posted Date
2018-04-04
Last Posted Date
2024-12-03
Lead Sponsor
Georgetown University
Target Recruit Count
45
Registration Number
NCT03487666
Locations
🇺🇸

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

🇺🇸

MedStar Washington Hospital Center, Washington, District of Columbia, United States

🇺🇸

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 1 locations

A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Breast Cancer
Interventions
First Posted Date
2018-03-22
Last Posted Date
2022-11-01
Lead Sponsor
University of Virginia
Target Recruit Count
13
Registration Number
NCT03473639
Locations
🇺🇸

University of Virginia, Charlottesville, Virginia, United States

🇺🇸

University of Rochester Medical Center, Rochester, New York, United States

A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer

Phase 2
Completed
Conditions
Gastric Cancer
GastroEsophageal Cancer
Interventions
First Posted Date
2018-03-21
Last Posted Date
2024-01-11
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
67
Registration Number
NCT03472365
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma

Phase 2
Completed
Conditions
Esophageal Squamous Cell Carcinoma, Gastric Carcinoma, Gastroesophageal Junction Carcinoma
Interventions
First Posted Date
2018-03-19
Last Posted Date
2024-10-23
Lead Sponsor
BeiGene
Target Recruit Count
30
Registration Number
NCT03469557
Locations
🇨🇳

Fifth Medical Center of Pla General Hospital, Beijing, Beijing, China

🇨🇳

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

🇨🇳

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China

and more 3 locations

Association of Capecitabine Pharmacokinetics and Toxicity With Aging

Phase 4
Conditions
Colorectal Cancer
Breast Cancer
Interventions
First Posted Date
2018-03-14
Last Posted Date
2018-03-14
Lead Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Target Recruit Count
100
Registration Number
NCT03465202

First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

Active, not recruiting
Conditions
Elderly Metastatic Colorectal Cancer Patients
First Posted Date
2018-03-01
Last Posted Date
2023-11-29
Lead Sponsor
Istituto Oncologico Veneto IRCCS
Target Recruit Count
121
Registration Number
NCT03451370
Locations
🇮🇹

Istituto Oncologico Veneto IRCCS, Padua, Italy

Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA)

Phase 2
Conditions
Stomach Cancer
Gastro Esophageal Junction Cancer
Interventions
First Posted Date
2018-02-28
Last Posted Date
2021-04-20
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
20
Registration Number
NCT03448835
Locations
🇳🇱

Marieke van de Belt, Amsterdam, Netherlands

🇳🇱

Catharina ziekenhuis, Eindhoven, Netherlands

A Bioequivalence Study of Capecitabine Tablets 500 mg in Adult Cancer Patients Under Fed Condition

Phase 1
Conditions
Colon Cancer
Breast Cancer
Interventions
First Posted Date
2018-02-19
Last Posted Date
2018-02-19
Lead Sponsor
Qilu Pharmaceutical Co., Ltd.
Target Recruit Count
45
Registration Number
NCT03435666

The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy

Phase 2
Conditions
Breast Cancer
Chemotherapy Effect
Disease-free Survival
Interventions
First Posted Date
2018-02-06
Last Posted Date
2018-02-06
Lead Sponsor
Zhiyong Yu
Target Recruit Count
200
Registration Number
NCT03423849
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