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

Bevacizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

Phase 3

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Drug: fluorouracil
Drug: capecitabine
Drug: irinotecan hydrochloride
Drug: leucovorin calcium

First Posted Date: 2008-11-25

Last Posted Date: 2013-08-26

Lead Sponsor: Southern Italy Cooperative Oncology Group

Target Recruit Count: 672

Registration Number: NCT00797485

Locations: 🇮🇹
Southern Italy Cooperative Oncology Group, Naples, Italy

Chemotherapeutic Agents in Brain/Breast

Completed

Conditions: Metastatic Cancer
Breast Cancer

First Posted Date: 2008-11-21

Last Posted Date: 2013-08-02

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 10

Registration Number: NCT00795678

Locations: 🇺🇸
Memorial Sloan Kettering, New York, New York, United States
🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct

Phase 2

Completed

Conditions: Gallbladder Cancer
Extrahepatic Bile Duct Cancer

Interventions: Drug: capecitabine
Drug: gemcitabine hydrochloride
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy

First Posted Date: 2008-11-13

Last Posted Date: 2018-04-09

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 105

Registration Number: NCT00789958

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center - Rockville Centre, Rockville Centre, New York, United States
🇺🇸
Great Falls Clinic - Main Facility, Great Falls, Montana, United States

and more 248 locations

Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer

Phase 2

Terminated

Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer

Interventions: Drug: sunitinib malate
Drug: capecitabine

First Posted Date: 2008-11-10

Last Posted Date: 2017-06-01

Lead Sponsor: University of Washington

Target Recruit Count: 41

Registration Number: NCT00787787

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma

Phase 2

Completed

Conditions: Stomach Cancer
Neoplasm of Cardioesophageal Junction
Gastric (Stomach) Cancer
Gastrointestinal Stromal Tumor (GIST)

Interventions: Drug: bevacizumab
Drug: carboplatin
Drug: capecitabine

First Posted Date: 2008-10-27

Last Posted Date: 2021-07-01

Lead Sponsor: Pamela L. Kunz

Target Recruit Count: 35

Registration Number: NCT00780494

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Phase 2

Completed

Conditions: Advanced Breast Cancer
Breast Cancer

Interventions: Drug: Neratinib
Drug: Lapatinib
Drug: Capecitabine

First Posted Date: 2008-10-22

Last Posted Date: 2018-08-09

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 233

Registration Number: NCT00777101

Locations: 🇿🇦
The Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
🇹🇭
Division of Medical Oncology, Department of Medicine, Bangkok-noi, Bangkok, Thailand
🇬🇧
Broomfield Hospital, Chelmsford, Essex, United Kingdom

and more 149 locations

Chemotherapy and Radiation Therapy Before Surgery Followed by Capecitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced Rectal Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

Interventions: Drug: capecitabine
Drug: oxaliplatin

First Posted Date: 2008-10-03

Last Posted Date: 2016-10-12

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 1094

Registration Number: NCT00766155

Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: Irinotecan
Drug: Capecitabine
Drug: Cetuximab
Drug: Oxaliplatin

First Posted Date: 2008-09-19

Last Posted Date: 2013-02-13

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 68

Registration Number: NCT00755534

Locations: 🇬🇷
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece
🇬🇷
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece
🇬🇷
University Hospital of Heraklion, Dep of Medical Oncology, Heraklion, Creta, Greece

and more 7 locations

Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

Interventions: Drug: capecitabine
Drug: fluorouracil
Drug: oxaliplatin

First Posted Date: 2008-09-09

Last Posted Date: 2018-07-27

Lead Sponsor: Cancer Research UK, Glasgow

Target Recruit Count: 6088

Registration Number: NCT00749450

Locations: 🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom

Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer

Phase 2

Terminated

Conditions: Recurrent Rectal Carcinoma
Stage IIA Rectal Cancer AJCC v7
Stage IIIA Rectal Cancer AJCC v7
Stage IIB Rectal Cancer AJCC v7
Stage IIC Rectal Cancer AJCC v7
Stage IIIB Rectal Cancer AJCC v7
Stage IIIC Rectal Cancer AJCC v7
Rectal Mucinous Adenocarcinoma
Rectal Signet Ring Cell Adenocarcinoma

Interventions: Drug: Capecitabine
Dietary Supplement: Curcumin
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Placebo
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy

First Posted Date: 2008-09-03

Last Posted Date: 2023-09-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 22

Registration Number: NCT00745134

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

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