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

The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer

Phase 3

Completed

Conditions: Gastric Cancer

Interventions: Drug: Oxaliplatin
Drug: Epirubicin
Drug: Capecitabine

First Posted Date: 2015-03-23

Last Posted Date: 2021-10-26

Lead Sponsor: Fudan University

Target Recruit Count: 438

Registration Number: NCT02395640

Locations: 🇨🇳
Fudan University Cancer Hospital, ShangHai, Shanghai, China

Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients With Locally Advanced Pancreatic Cancer

Phase 1

Completed

Conditions: Locally Advanced Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer AJCC v6 and v7
Stage IIA Pancreatic Cancer AJCC v6 and v7
Pancreatic Adenocarcinoma
Stage II Pancreatic Cancer AJCC v6 and v7
Stage IIB Pancreatic Cancer AJCC v6 and v7
Borderline Resectable Pancreatic Adenocarcinoma

Interventions: Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Drug: Nab-paclitaxel
Other: Questionnaire Administration
Radiation: Radiation Therapy

First Posted Date: 2015-03-20

Last Posted Date: 2022-09-02

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT02394535

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
MD Anderson Cancer Center - League City, League City, Texas, United States
🇺🇸
MD Anderson in Sugar Land, Sugar Land, Texas, United States

and more 2 locations

Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Rectal Adenocarcinoma
Recurrent Colon Carcinoma
Recurrent Rectal Carcinoma
Stage IVA Rectal Cancer
Stage IVA Colon Cancer
Stage IVB Rectal Cancer
Colon Adenocarcinoma
Stage IVB Colon Cancer

Interventions: Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Drug: Nintedanib
Other: Pharmacological Study

First Posted Date: 2015-03-19

Last Posted Date: 2021-07-08

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 42

Registration Number: NCT02393755

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers

Phase 3

Conditions: Rectal Cancer

Interventions: Procedure: Additional TME surgery
Radiation: Adjuvant chemoradiotherapy
Drug: capecitabine

First Posted Date: 2015-02-25

Last Posted Date: 2020-05-21

Lead Sponsor: Amsterdam UMC, location VUmc

Target Recruit Count: 302

Registration Number: NCT02371304

Locations: 🇳🇱
VU University Medical Center, Amsterdam, Netherlands

Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma

Phase 2

Completed

Conditions: Nasopharyngeal Neoplasms

Interventions: Drug: Docetaxel
Drug: Cisplatin
Drug: Capecitabine

First Posted Date: 2015-02-10

Last Posted Date: 2016-04-20

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 50

Registration Number: NCT02360501

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

A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer

Phase 1

Completed

Conditions: Stomach Neoplasms

Interventions: Drug: Ramucirumab
Drug: Capecitabine
Drug: Cisplatin
Drug: S-1
Drug: Oxaliplatin

First Posted Date: 2015-02-09

Last Posted Date: 2018-01-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 18

Registration Number: NCT02359058

Locations: 🇯🇵
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician., Ehime, Japan
🇯🇵
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician, Osaka, Japan

Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study

Phase 2

Completed

Conditions: Midgut Neuroendocrine Tumours
Pancreatic Neuroendocrine Tumours

Interventions: Drug: octreotate
Drug: Capecitabine
Drug: Temozolomide

First Posted Date: 2015-02-09

Last Posted Date: 2022-07-05

Lead Sponsor: Australasian Gastro-Intestinal Trials Group

Target Recruit Count: 75

Registration Number: NCT02358356

Locations: 🇦🇺
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
🇦🇺
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
🇦🇺
Royal North Shore Hospital, St Leonards, New South Wales, Australia

and more 1 locations