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

Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

Phase 1

Active, not recruiting

Conditions: Carcinoma

Interventions: Drug: Intraperitoneal Oxaliplatin
Drug: Bevacizumab
Drug: Capecitabine

First Posted Date: 2010-02-03

Last Posted Date: 2024-11-18

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 21

Registration Number: NCT01061515

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

Phase 2

Completed

Conditions: Rectal Neoplasms

Interventions: Radiation: External beam radiation
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5-FU
Drug: Capecitabine

First Posted Date: 2010-02-01

Last Posted Date: 2017-03-08

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 80

Registration Number: NCT01060007

Locations: 🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States

Study of Perifosine + Capecitabine for Colon Cancer Patients

Phase 1

Completed

Conditions: Colon Cancer

Interventions: Drug: Perifosine
Drug: Capecitabine

First Posted Date: 2010-01-13

Last Posted Date: 2018-06-28

Lead Sponsor: AEterna Zentaris

Target Recruit Count: 10

Registration Number: NCT01048580

Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck

Phase 2

Completed

Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IV Verrucous Carcinoma of the Larynx
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Oropharynx

Interventions: Drug: lapatinib ditosylate
Drug: capecitabine

First Posted Date: 2010-01-07

Last Posted Date: 2020-03-19

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 44

Registration Number: NCT01044433

Locations: 🇺🇸
Abramson Cancer Center of The University of Pennsylvania, Philadelphia, Pennsylvania, United States

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Phase 3

Completed

Conditions: Gastric Cancer

Interventions: Drug: Trastuzumab
Drug: Fluorouracil
Drug: Cisplatin
Drug: Capecitabine

First Posted Date: 2009-12-31

Last Posted Date: 2014-11-05

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 584

Registration Number: NCT01041404

Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: capecitabine
Drug: gemcitabine hydrochloride
Procedure: quality-of-life assessment
Radiation: 3-dimensional conformal radiation therapy

First Posted Date: 2009-12-15

Last Posted Date: 2018-10-26

Lead Sponsor: Lisette Nixon

Target Recruit Count: 114

Registration Number: NCT01032057

Locations: 🇬🇧
Glan Clwyd Hospital, Rhyl, Denbighshire, Wales, United Kingdom
🇬🇧
Musgrove Park Hospital, Taunton, England, United Kingdom
🇬🇧
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom

and more 23 locations

A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Capecitabine
Drug: Pertuzumab
Drug: Trastuzumab

First Posted Date: 2009-12-04

Last Posted Date: 2018-08-14

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 452

Registration Number: NCT01026142

Locations: 🇧🇪
UZ Brussel, Brussel, Belgium
🇭🇰
Queen Mary Hospital; Surgery, Hong Kong, Hong Kong
🇷🇺
Semashko Central Clinical Hospital; Dept of Chemotherapy, Moscow, Russian Federation

and more 187 locations

Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Oxaliplatin
Drug: Capecitabine
Drug: Bevacizumab

First Posted Date: 2009-12-02

Last Posted Date: 2010-04-09

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 46

Registration Number: NCT01024504

Locations: 🇬🇷
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece
🇬🇷
Air Forces Military Hospital of Athens, Athens, Greece
🇬🇷
IASO General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece

and more 3 locations