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

Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors

Phase 2

Active, not recruiting

Conditions: Gastrinoma
Somatostatinoma
Glucagonoma
Recurrent Islet Cell Carcinoma
Insulinoma
Islet Cell Carcinoma
Pancreatic Polypeptide Tumor

Interventions: Drug: temozolomide
Drug: capecitabine

First Posted Date: 2013-04-05

Last Posted Date: 2024-02-07

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 144

Registration Number: NCT01824875

Locations: 🇺🇸
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
🇺🇸
Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States
🇺🇸
Oncology Hematology Care Inc - Western Hills, Cincinnati, Ohio, United States

and more 318 locations

Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin

Phase 2

Terminated

Conditions: Squamous Cell Carcinoma of the Skin
Recurrent Skin Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2013-04-04

Last Posted Date: 2018-04-12

Lead Sponsor: Stanford University

Target Recruit Count: 2

Registration Number: NCT01823679

Locations: 🇺🇸
Stanford University Hospitals and Clinics, Stanford, California, United States

Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients With Pancreatic Cancer

Early Phase 1

Completed

Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer

Interventions: Drug: oxaliplatin
Drug: irinotecan
Drug: leucovorin
Drug: 5-fluorouracil
Drug: capecitabine
Radiation: radiation
Procedure: surgery
Drug: gemcitabine

First Posted Date: 2013-04-01

Last Posted Date: 2018-09-04

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 23

Registration Number: NCT01821612

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

and more 11 locations

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

Phase 3

Completed

Conditions: HER2+ Metastatic Breast Cancer (MBC)

Interventions: Drug: neratinib
Drug: capecitabine
Drug: lapatinib

First Posted Date: 2013-03-11

Last Posted Date: 2021-06-11

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 621

Registration Number: NCT01808573

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States
🇺🇸
University of California San Diego Medical Center - Hillcrest, San Diego, California, United States
🇺🇸
Sharp Memorial Hospital, San Diego, California, United States

and more 233 locations

Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer

Phase 3

Active, not recruiting

Conditions: Cancer of the Rectum

Interventions: Radiation: Radiotherapy 50 Gy
Drug: mFolfirinox
Drug: Capecitabine
Procedure: TME surgery
Drug: mFolfox6 or capecitabine

First Posted Date: 2013-03-05

Last Posted Date: 2024-09-30

Lead Sponsor: UNICANCER

Target Recruit Count: 461

Registration Number: NCT01804790

Locations: 🇫🇷
Gustave Roussy, Villejuif, France
🇫🇷
ICO - Site Paul Papin, Angers, France
🇫🇷
Centre hospitalier Universitaire d'Amiens, Amiens, France

and more 32 locations

XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

Phase 2

Conditions: Gastric Cancer

Interventions: Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2013-02-25

Last Posted Date: 2013-05-06

Lead Sponsor: Harbin Medical University

Target Recruit Count: 40

Registration Number: NCT01798251

Locations: 🇨🇳
The tumor hospital of Harbin medical university, Harbin, Heilongjiang, China

A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Capecitabine
Drug: Everolimus
Drug: Exemestane

First Posted Date: 2013-02-05

Last Posted Date: 2021-02-26

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 309

Registration Number: NCT01783444

Locations: 🇺🇸
University of California at Los Angeles Mattel Children's Hospital, Los Angeles, California, United States
🇺🇸
Sharp Memorial Hospital SharpClinicalOncologyResearch, San Diego, California, United States
🇺🇸
Oncology Hematology Care Inc Oncology Hematology Care 2, Cincinnati, Ohio, United States

and more 17 locations

Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis

Phase 1

Completed

Conditions: HER2-positive Breast Cancer
Central Nervous System Metastases
Male Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer

Interventions: Drug: lapatinib ditosylate
Drug: everolimus
Drug: capecitabine
Other: laboratory biomarker analysis

First Posted Date: 2013-02-05

Last Posted Date: 2019-11-12

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 9

Registration Number: NCT01783756

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer

Completed

Conditions: Breast Cancer

Interventions: Drug: capecitabine
Drug: docetaxel

First Posted Date: 2013-01-29

Last Posted Date: 2016-08-19

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 46

Registration Number: NCT01777945

A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: BBI608
Drug: Cetuximab
Drug: Capecitabine
Drug: Panitumumab

First Posted Date: 2013-01-28

Last Posted Date: 2023-11-15

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 200

Registration Number: NCT01776307

Locations: 🇺🇸
USOR - Texas Oncology Tyler, Tyler, Texas, United States
🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
US Oncology Research, The Woodlands, Texas, United States

and more 8 locations

Drug Development Updates

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