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 chemother...

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

Capecitabine and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer or Other Pelvic Cancer

Phase 1

Withdrawn

Conditions: Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Vaginal Cancer

First Posted Date: 2005-07-11

Last Posted Date: 2011-07-08

Lead Sponsor: Case Comprehensive Cancer Center

Registration Number: NCT00118300

Locations: 🇺🇸
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Docetaxel Followed by CEF (Cyclophosphamide, Epirubicin and 5-Fluorouracil) Compared to Docetaxel and Capecitabine Followed by CEX (Cyclophosphamide, Epirubicin and Capecitabine) as Adjuvant Treatment for Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

First Posted Date: 2005-06-20

Last Posted Date: 2007-05-21

Lead Sponsor: Finnish Breast Cancer Group

Target Recruit Count: 1500

Registration Number: NCT00114816

Locations: 🇫🇮
Department of Oncology, Helsinki University Central Hospital, Finland, Helsinki, Finland

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

Phase 2

Completed

Conditions: Adenocarcinoma of the Pancreas
Stage III Pancreatic Cancer
Stage II Pancreatic Cancer

Interventions: Drug: capecitabine
Radiation: radiation therapy
Biological: bevacizumab
Procedure: therapeutic conventional surgery
Drug: gemcitabine hydrochloride

First Posted Date: 2005-06-14

Last Posted Date: 2020-10-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 82

Registration Number: NCT00114179

Locations: 🇺🇸
Radiation Therapy Oncology Group, Philadelphia, Pennsylvania, United States

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: capecitabine
Drug: oxaliplatin
Procedure: neoadjuvant therapy
Radiation: radiation therapy

First Posted Date: 2005-06-14

Last Posted Date: 2018-03-29

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 90

Registration Number: NCT00114231

Locations: 🇺🇸
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
🇺🇸
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States

and more 64 locations

Carboplatin, Capecitabine, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Phase 1

Completed

Conditions: Head and Neck Cancer

First Posted Date: 2005-06-14

Last Posted Date: 2009-11-26

Lead Sponsor: University of Virginia

Target Recruit Count: 48

Registration Number: NCT00114153

Locations: 🇺🇸
University of Virginia Cancer Center at UV Health System, Charlottesville, Virginia, United States

Neoadjuvant Chemoradiation With RHUMAB VEGF (Avastin) for Rectal Cancer

Phase 2

Completed

Conditions: Rectal Cancer

Interventions: Drug: Avastin (Bevacizumab, RHUMAB VEGF)
Drug: Capecitabine
Radiation: Radiation Therapy

First Posted Date: 2005-06-07

Last Posted Date: 2012-08-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT00113230

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

Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

Interventions: Biological: Bevacizumab
Drug: 5-Fluorouracil (5-FU)
Drug: Leucovorin calcium
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2005-06-03

Last Posted Date: 2013-08-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 3451

Registration Number: NCT00112918

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

S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: capecitabine
Drug: cyclophosphamide

First Posted Date: 2005-04-06

Last Posted Date: 2013-07-18

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 112

Registration Number: NCT00107276

Locations: 🇺🇸
Big Sky Oncology, Great Falls, Montana, United States
🇺🇸
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
🇺🇸
Kaiser Permanente Medical Center - Redwood City, Redwood City, California, United States

and more 141 locations

Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

First Posted Date: 2005-04-06

Last Posted Date: 2013-07-10

Lead Sponsor: Tohoku University

Target Recruit Count: 75

Registration Number: NCT00107393

Locations: 🇯🇵
Hokkaido Cancer Center, Hokkaido, Japan
🇯🇵
Hiroshima University Hospital, Hiroshima, Japan
🇯🇵
Saint Marianna University School of Medicine, Kanagawa, Japan

and more 7 locations

Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Drug: capecitabine

First Posted Date: 2005-04-06

Last Posted Date: 2014-07-04

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 16

Registration Number: NCT00107315

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Drug Development Updates

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