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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 Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer

Phase 2
Completed
Conditions
Carcinoma, Hepatocellular
Interventions
First Posted Date
2015-10-15
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
16
Registration Number
NCT02576964

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

First Posted Date
2015-10-12
Last Posted Date
2022-06-15
Lead Sponsor
Gilead Sciences
Target Recruit Count
529
Registration Number
NCT02574455
Locations
🇺🇸

Southern Cancer Center, 29653 Anchor Cross Blvd, Daphne, Alabama, United States

🇺🇸

Souther Cancer Center, 3719 Dauphin St., 5 Floor, Mobile, Alabama, United States

🇺🇸

Southern Cancer Center, 3 Mobile Infirmary Circle, Mobile, Alabama, United States

and more 175 locations

A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer

Phase 4
Completed
Conditions
Colorectal Cancer
Interventions
First Posted Date
2015-10-02
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
28
Registration Number
NCT02567331

A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer

Phase 2
Completed
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2015-10-01
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
63
Registration Number
NCT02565641

A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

Phase 3
Completed
Conditions
Gastric Cancer
Interventions
First Posted Date
2015-09-29
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
316
Registration Number
NCT02563054

A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer

Phase 3
Completed
Conditions
Gastric Cancer
Interventions
First Posted Date
2015-09-25
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1035
Registration Number
NCT02560974

Cisplatin and Fluorouracil Compared With Carboplatin and Paclitaxel in Treating Patients With Inoperable Locally Recurrent or Metastatic Anal Cancer

Phase 2
Active, not recruiting
Conditions
Anal Basaloid Carcinoma
Stage IV Anal Canal Cancer
Recurrent Anal Canal Carcinoma
Anal Squamous Cell Carcinoma
Metastatic Anal Canal Carcinoma
Stage IIIB Anal Canal Cancer
Anal Canal Cloacogenic Carcinoma
Interventions
Drug: Capecitabine
Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Cisplatin
Drug: Fluorouracil
Drug: Paclitaxel
Other: Quality-of-Life Assessment
First Posted Date
2015-09-25
Last Posted Date
2023-06-22
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
91
Registration Number
NCT02560298
Locations
🇺🇸

ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

Phase 2
Completed
Conditions
Biliary Tract Neoplasms
Interventions
First Posted Date
2015-09-24
Last Posted Date
2018-02-13
Lead Sponsor
Zhejiang University
Target Recruit Count
64
Registration Number
NCT02558959
Locations
🇨🇳

First affiliated hospital, Zhejiang University, Hangzhou, Zhejiang, China

Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)

Phase 3
Completed
Conditions
Metastatic Triple Negative Breast Cancer
Interventions
First Posted Date
2015-09-21
Last Posted Date
2021-12-10
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
622
Registration Number
NCT02555657

Neoadjuvant Treatment for Advanced Rectal Carcinoma

Phase 3
Completed
Conditions
Rectal Carcinoma
Interventions
Radiation: 25 Gy
Radiation: 50 Gy
Drug: Capecitabine
First Posted Date
2015-09-16
Last Posted Date
2023-10-13
Lead Sponsor
UNICANCER
Target Recruit Count
103
Registration Number
NCT02551237
Locations
🇫🇷

Hôpital Avicenne, Bobigny, France

🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

CHU Henri Mondor, Créteil, France

and more 34 locations
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