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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

Colon Neoadjuvant FOLFOXIRI Study

Phase 2
Active, not recruiting
Conditions
Rectal Cancer
Interventions
Drug: neoadjuvant FOLFOXIRI
Drug: Capecitabine
First Posted Date
2013-09-13
Last Posted Date
2024-06-24
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
40
Registration Number
NCT01941641
Locations
🇭🇰

Department of Clinical Oncology, Hong Kong, Hong Kong

Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients

Phase 2
Conditions
Breast Cancer
Interventions
First Posted Date
2013-09-11
Last Posted Date
2015-06-04
Lead Sponsor
Chinese Academy of Medical Sciences
Target Recruit Count
90
Registration Number
NCT01939054
Locations
🇨🇳

Xijing Hospital, Xi-an, Shanxi, China

🇨🇳

The General Hospital of the People's Liberation Army (PLAGH), Beijing, Beijing, China

🇨🇳

Beijing cancer hospital, Beijing, Beijing, China

and more 6 locations

Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer

Phase 2
Conditions
Breast Cancer
Interventions
Drug: Capecitabine
Drug: aromatase Inhibitors (AIs)
First Posted Date
2013-08-16
Last Posted Date
2013-08-16
Lead Sponsor
Fudan University
Target Recruit Count
100
Registration Number
NCT01924078
Locations
🇨🇳

FUSCC, Shanghai, Shanghai, China

High or Standard Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-paclitaxel in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

Phase 2
Terminated
Conditions
Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer
Interventions
Radiation: low intensity radiation therapy
Drug: Capecitabine
Drug: nab-Paclitaxel
Drug: Gemcitabine
Radiation: high intensity radiation therapy
First Posted Date
2013-08-13
Last Posted Date
2018-07-13
Lead Sponsor
Radiation Therapy Oncology Group
Target Recruit Count
20
Registration Number
NCT01921751
Locations
🇺🇸

Radiation Oncology Associates PC, Fort Wayne, Indiana, United States

🇺🇸

University of Rochester, Rochester, New York, United States

🇺🇸

Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

and more 43 locations

S-1 Versus Capecitabine in the First Line Treatment of MCC Patients.

Phase 3
Completed
Conditions
Colorectal Cancer
Metastases
Interventions
First Posted Date
2013-08-08
Last Posted Date
2018-03-14
Lead Sponsor
Dutch Colorectal Cancer Group
Target Recruit Count
161
Registration Number
NCT01918852
Locations
🇳🇱

Slingeland Ziekenhuis, Doetinchem, Netherlands

🇳🇱

Orbis Medisch Centrum, Sittard, Netherlands

🇳🇱

Tweesteden Ziekenhuis, Tilburg, Netherlands

and more 21 locations

Neoadjuvant SBRT With Concomitant Capecitabine in Resectable Pancreatic Cancer

Phase 1
Completed
Conditions
Stage IB Pancreatic Cancer
Stage IA Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Interventions
Radiation: stereotactic body radiation therapy
Drug: capecitabine
Procedure: therapeutic conventional surgery
Procedure: magnetic resonance imaging
Other: laboratory biomarker analysis
First Posted Date
2013-08-08
Last Posted Date
2022-06-01
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
21
Registration Number
NCT01918644
Locations
🇺🇸

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

Phase 3
Active, not recruiting
Conditions
Colon Cancer
Interventions
First Posted Date
2013-08-07
Last Posted Date
2024-04-16
Lead Sponsor
Vejle Hospital
Target Recruit Count
250
Registration Number
NCT01918527
Locations
🇩🇰

Vejle Hospital, Vejle, Denmark

🇸🇪

Sahlgrenska University Hospital, Göteborg, Sweden

🇩🇰

Rigshospitalet, Copenhagen, Denmark

and more 6 locations

Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS

Phase 3
Recruiting
Conditions
Gastric Cancer
Interventions
First Posted Date
2013-08-06
Last Posted Date
2024-02-28
Lead Sponsor
Asan Medical Center
Target Recruit Count
870
Registration Number
NCT01917552
Locations
🇰🇷

Asan Medical Center, Seoul, Songpa-gu, Korea, Republic of

Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

Phase 2
Conditions
Locally Advanced Rectal Cancer
Interventions
Radiation: Preoperative irradiation
Drug: Nimotuzumab
Drug: Oxaliplatin
Drug: Capecitabine
First Posted Date
2013-07-15
Last Posted Date
2013-07-15
Lead Sponsor
Zhejiang Cancer Hospital
Target Recruit Count
50
Registration Number
NCT01899118
Locations
🇨🇳

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Preoperative Valproic Acid and Radiation Therapy for Rectal Cancer

Phase 1
Recruiting
Conditions
Colorectal Cancer
Interventions
Radiation: preoperative radiation therapy
Drug: Capecitabine
Drug: Valproic Acid
First Posted Date
2013-07-12
Last Posted Date
2023-03-24
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
152
Registration Number
NCT01898104
Locations
🇮🇹

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy

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