Capecitabine

Generic Name: Capecitabine

Brand Names: Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₂₂FN_₃O_₆

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

Clinical Trials

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

Phase 3

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Palbociclib
Drug: Capecitabine
Drug: Exemestane
Drug: Fulvestrant

First Posted Date: 2014-01-07

Last Posted Date: 2021-01-20

Lead Sponsor: Spanish Breast Cancer Research Group

Target Recruit Count: 693

Registration Number: NCT02028507

Locations: 🇮🇱
Sheba Medical Center, Tel Hashomer, Israel
🇦🇹
Universitätsklinik für Innere Medizin III, Salzburg, Austria
🇦🇹
Landes-Krankenhaus Steyr, Steyr, Austria

and more 34 locations

Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer

Not Applicable

Conditions: Breast Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2014-01-07

Last Posted Date: 2018-09-07

Lead Sponsor: Latin American & Caribbean Society of Medical Oncology

Target Recruit Count: 350

Registration Number: NCT02028494

Locations: 🇦🇷
SLACOM, Buenos Aires, Argentina

Maintenance Treatment With Capecitabine in Colorectal Cancer Patients

Phase 2

Conditions: Colorectal Neoplasms
Neoplasms Metastasis

Interventions: Other: Observation
Drug: Capecitabine

First Posted Date: 2014-01-06

Last Posted Date: 2014-01-06

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 245

Registration Number: NCT02027363

Locations: 🇨🇳
Medical Oncology,Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

Phase 1

Completed

Conditions: HER2 Positive Metastatic Breast Cancers

Interventions: Drug: Tucatinib
Drug: Capecitabine
Drug: Trastuzumab

First Posted Date: 2013-12-31

Last Posted Date: 2020-06-04

Lead Sponsor: Seagen Inc.

Target Recruit Count: 60

Registration Number: NCT02025192

Locations: 🇺🇸
University of Colorado, Aurora, Colorado, United States
🇺🇸
Northwest Medical Specialties, Tacoma, Washington, United States
🇺🇸
Providence Cancer Center, Portland, Oregon, United States

and more 2 locations

A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer

Phase 1

Completed

Conditions: Advanced Gastrointestinal Cancer

Interventions: Drug: BBI608
Drug: Fluorouracil
Drug: Regorafenib
Drug: Leucovorin
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Irinotecan
Drug: Bevacizumab

First Posted Date: 2013-12-31

Last Posted Date: 2023-11-15

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 495

Registration Number: NCT02024607

Locations: 🇺🇸
Parkview Research Center, Fort Wayne, Indiana, United States
🇺🇸
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Indiana University Health Goshen Center for Cancer Care, Goshen, Indiana, United States

and more 12 locations

Systemic Therapy and Chemoradiation in Advanced Localised Pancreatic Cancer - 2

Phase 1

Completed

Conditions: Pancreatic Neoplasms (Locally Advanced Non-metastatic)

Interventions: Drug: nab-paclitaxel
Radiation: 50.4Gy in 28#
Radiation: 60Gy in 30#
Drug: Nelfinavir
Drug: Capecitabine
Drug: Gemcitabine

First Posted Date: 2013-12-31

Last Posted Date: 2024-07-25

Lead Sponsor: University of Oxford

Target Recruit Count: 159

Registration Number: NCT02024009

Locations: 🇬🇧
University Hospitals Coventry and Warwickshire NHS Trust, University Hospital Coventry, Coventry, United Kingdom
🇬🇧
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom
🇬🇧
East Suffolk and North Essex NHS Foundation Trust, Colchester District General Hospital, Colchester, United Kingdom

and more 20 locations

Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

Phase 2

Conditions: Rectal Cancer

Interventions: Drug: XELOX
Drug: Capecitabine

First Posted Date: 2013-12-30

Last Posted Date: 2013-12-30

Lead Sponsor: Harbin Medical University

Target Recruit Count: 80

Registration Number: NCT02022852

Locations: 🇨🇳
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

Phase 1

Completed

Conditions: Prostate Cancer
Pancreatic Carcinoma
Solid Tumors
Breast Cancer
Melanoma
Renal Cell Carcinoma
Non-small Cell Lung Carcinoma
Ovarian Cancer
Colorectal Carcinoma

Interventions: Drug: Gemcitabine/carboplatin
Drug: Pegilodecakin
Drug: nivolumab
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Drug: gemcitabine/nab-paclitaxel
Drug: Capecitabine
Drug: Pazopanib
Drug: Paclitaxel
Drug: Pembrolizumab

First Posted Date: 2013-12-12

Last Posted Date: 2024-11-15

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 353

Registration Number: NCT02009449

Locations: 🇺🇸
UCLA Medical Hematology & Oncology, Los Angeles, California, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Florida Cancer Specialists & Research Institute, Sarasota, Florida, United States

and more 7 locations

Neoadjuvant Chemoradiotherapy With CRLX-101 and Capecitabine for Rectal Cancer

Phase 1

Terminated

Conditions: Rectal Cancer

Interventions: Drug: CRLX101
Drug: Capecitabine
Radiation: Radiotherapy
Procedure: Surgery

First Posted Date: 2013-12-12

Last Posted Date: 2020-11-03

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 32

Registration Number: NCT02010567

Locations: 🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States
🇺🇸
Rocky Mountain Cancer Center, Denver, Colorado, United States
🇺🇸
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States

and more 3 locations

MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer

Phase 2

Conditions: Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: capecitabine
Drug: Docetaxel

First Posted Date: 2013-12-10

Last Posted Date: 2019-02-27

Lead Sponsor: International Group of Endovascular Oncology

Target Recruit Count: 51

Registration Number: NCT02007148

Locations: 🇮🇹
AORMN, Presidio Ospedaliero San Salvatore, Pesaro, Italy
🇮🇹
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore, Pesaro, Italy

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