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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

Radiotherapy With Chemotherapy as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer

Phase 2
Conditions
Pancreatic Cancer
Interventions
Drug: Capecitabine
Radiation: Standard Dose Acclerated Fraction Radiotherapy
First Posted Date
2011-04-11
Last Posted Date
2011-04-11
Lead Sponsor
University of Virginia
Target Recruit Count
35
Registration Number
NCT01333332
Locations
🇺🇸

University of Virginia, Charlottesville, Virginia, United States

GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
Solid Cancers
Interventions
Drug: GDC-0980
Drug: bevacizumab
Drug: capecitabine
Drug: mFOLFOX6
First Posted Date
2011-04-11
Last Posted Date
2016-11-02
Lead Sponsor
Genentech, Inc.
Target Recruit Count
41
Registration Number
NCT01332604

Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
Drug: TRC105
Drug: Capecitabine
First Posted Date
2011-03-31
Last Posted Date
2019-03-18
Lead Sponsor
Tracon Pharmaceuticals Inc.
Target Recruit Count
19
Registration Number
NCT01326481
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

A Confirmation Study of Eribulin in Combination With Capecitabine

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2011-03-25
Last Posted Date
2021-01-11
Lead Sponsor
Eisai Limited
Target Recruit Count
76
Registration Number
NCT01323530

Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer

First Posted Date
2011-03-03
Last Posted Date
2017-08-09
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
2000
Registration Number
NCT01308086
Locations
🇬🇷

University Hospital of Crete, Dep of Medical Oncology, Heraklion, Greece

Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma

Phase 1
Withdrawn
Conditions
Stage II Rectal Cancer
Stage III Rectal Cancer
Interventions
Drug: Capecitabine
Drug: 5-FU
Drug: Leucovorin
Drug: Oxaliplatin
Radiation: radiation
Procedure: total mesorectal excision
First Posted Date
2011-02-24
Last Posted Date
2020-08-20
Lead Sponsor
University of Texas Southwestern Medical Center
Registration Number
NCT01302613
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2011-02-23
Last Posted Date
2023-12-04
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
47
Registration Number
NCT01300962
Locations
🇺🇸

Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

🇺🇸

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas

Phase 1
Completed
Conditions
Pancreatic Cancer
Interventions
Biological: ganitumab
Drug: capecitabine
Drug: gemcitabine hydrochloride
Radiation: 3-dimensional conformal radiation therapy
First Posted Date
2011-02-17
Last Posted Date
2015-11-17
Lead Sponsor
Radiation Therapy Oncology Group
Target Recruit Count
8
Registration Number
NCT01298401
Locations
🇺🇸

CCOP - Christiana Care Health Services, Newark, Delaware, United States

🇺🇸

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States

🇺🇸

James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States

and more 7 locations

Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer

Not Applicable
Completed
Conditions
Adenocarcinoma
Interventions
First Posted Date
2011-02-14
Last Posted Date
2020-11-02
Lead Sponsor
Odense University Hospital
Target Recruit Count
27
Registration Number
NCT01295086
Locations
🇩🇰

Aalborg University Hospital, Aalborg, Denmark

🇩🇰

Aarhus University Hospital, Aarhus, Denmark

🇩🇰

Rigshospitalet, Copenhagen, Denmark

and more 1 locations

Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Not Applicable
Terminated
Conditions
Metastatic Colorectal Cancer
Interventions
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: irinotecan hydrochloride
Drug: capecitabine
Genetic: mutation analysis
Biological: bevacizumab
Biological: cetuximab
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Genetic: nucleic acid sequencing
Genetic: protein expression analysis
Genetic: polymerase chain reaction
Genetic: DNA analysis
First Posted Date
2011-01-21
Last Posted Date
2021-03-15
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
3
Registration Number
NCT01280643
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

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