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

CONVERT: Neoadjuvant Chemotherapy Alone Versus Preoperative Chemoradiation for Locally Advanced Rectal Cancer Patients

Phase 3

Active, not recruiting

Conditions: Rectal Neoplasms

Interventions: Drug: Oxaliplatin
Drug: capecitabine
Radiation: Radiation

First Posted Date: 2014-11-11

Last Posted Date: 2023-05-12

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 663

Registration Number: NCT02288195

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

Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction

Phase 2

Completed

Conditions: Adenocarcinoma of the Esophagogastric Junction

Interventions: Drug: Oxaliplatin
Drug: Epirubicin
Drug: Capecitabine
Drug: 5-FU
Drug: Carboplatin
Drug: Paclitaxel
Radiation: radiation
Procedure: Biopsy

First Posted Date: 2014-11-10

Last Posted Date: 2023-11-28

Lead Sponsor: Technical University of Munich

Target Recruit Count: 75

Registration Number: NCT02287129

Locations: 🇩🇪
2nd department of the Medical Clinic of the Technical University Munich, Munich, Bavaria, Germany

Low Dose Metronomic Poly-chemotherapy for Metastatic CRC

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Capecitabine
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: Celecoxib

First Posted Date: 2014-10-31

Last Posted Date: 2020-02-12

Lead Sponsor: HaEmek Medical Center, Israel

Target Recruit Count: 45

Registration Number: NCT02280694

Locations: 🇮🇱
Gastrointestinal Oncology Unit, Institute of Oncology, Davidoff Center, Rabin Medical Center, Belinson Campus,, Petach Tiqva, Israel

IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment

Phase 2

Conditions: Rectal Carcinoma

Interventions: Radiation: IMRT-SIB
Drug: Capecitabine
Procedure: Surgery

First Posted Date: 2014-10-20

Last Posted Date: 2014-10-20

Lead Sponsor: Institute of Oncology Ljubljana

Target Recruit Count: 50

Registration Number: NCT02268006

Locations: 🇸🇮
Institute of Oncology, Ljubljana, Slovenia

Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Capecitabine
Drug: UTD1 Injection plus capecitabine

First Posted Date: 2014-10-01

Last Posted Date: 2019-04-09

Lead Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

Target Recruit Count: 405

Registration Number: NCT02253459

Locations: 🇨🇳
Henan Cancer Hospital, Zhengzhou, Henan, China
🇨🇳
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
🇨🇳
The General Hospital of the People's Liberation Army, Beijing, Beijing, China

and more 8 locations

T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy

Phase 2

Conditions: Gastric Cancer

Interventions: Drug: Trastuzumab
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2014-09-26

Last Posted Date: 2014-09-26

Lead Sponsor: Chinese PLA General Hospital

Target Recruit Count: 40

Registration Number: NCT02250209

Locations: 🇨🇳
Chinese PLA General Hospital, Beijing, Beijing, China

Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab

Phase 4

Completed

Conditions: Breast Cancer Recurrent
Hormone Receptor Positive Malignant Neoplasm of Breast
HER2/Neu-negative Carcinoma of Breast

Interventions: Drug: Bevacizumab
Drug: Capecitabine
Drug: Everolimus
Drug: Exemestane
Other: Patient questionaires

First Posted Date: 2014-09-25

Last Posted Date: 2017-11-13

Lead Sponsor: iOMEDICO AG

Target Recruit Count: 85

Registration Number: NCT02248571

Locations: 🇩🇪
iOMEDICO AG, Freiburg, Baden-Wuerttemberg, Germany

Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Phase 1

Terminated

Conditions: Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Momelotinib (MMB)
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2014-09-19

Last Posted Date: 2019-02-01

Lead Sponsor: Sierra Oncology LLC - a GSK company

Target Recruit Count: 16

Registration Number: NCT02244489

Locations: 🇺🇸
Scottsdale Healthcare Research Institute, Scottsdale, Arizona, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Tennessee Oncology, Nashville, Tennessee, United States

and more 1 locations

Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

Phase 2

Terminated

Conditions: Resectable Pancreatic Cancer
Pancreatic Ductal Carcinoma

Interventions: Drug: FOLFIRINOX
Drug: Gemcitabine/nab-Paclitaxel
Radiation: Radiation therapy
Drug: Capecitabine

First Posted Date: 2014-09-17

Last Posted Date: 2017-05-16

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 7

Registration Number: NCT02243007

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma

Phase 2

Completed

Conditions: Squamous Cell Carcinoma of Skin
Carcinoma, Squamous Cell

Interventions: Drug: Pegylated Interferon alpha-2b
Drug: Capecitabine
Drug: 5-FU

First Posted Date: 2014-08-15

Last Posted Date: 2022-10-07

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 8

Registration Number: NCT02218164

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Drug Development Updates

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