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

Total Neoadjuvant Induction and Consolidation CapeOX Plus IMRT With Capecitabine for MRI Defined High-risk Rectal Cancer

Phase 2

Completed

Conditions: Rectal Cancer

Interventions: Drug: Oxaliplatin
Drug: Capecitabine
Radiation: Intensity modulated radiotherapy
Procedure: Total mesorectal excision

First Posted Date: 2016-08-12

Last Posted Date: 2021-07-23

Lead Sponsor: Peking University Cancer Hospital & Institute

Target Recruit Count: 81

Registration Number: NCT02864849

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China

CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer
Colon Cancer
Rectal Cancer
Solid Tumor

Interventions: Drug: CB-839
Drug: Capecitabine

First Posted Date: 2016-08-10

Last Posted Date: 2024-12-19

Lead Sponsor: David Bajor, MD

Target Recruit Count: 50

Registration Number: NCT02861300

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

Tailored Operative or Non-operative Management for Low-risk Rectal Cancer After Intensive Neoadjuvant Treatment

Completed

Conditions: Rectal Cancer

Interventions: Drug: Oxaliplatin
Drug: Capecitabine
Radiation: intensity modulated radiotherapy
Procedure: DRE-Endoscopy-MRI-CEA
Procedure: Nonoperative Management
Procedure: Total Mesorectal Excision
Behavioral: Quality of Life Questionnaires
Procedure: Local Excision

First Posted Date: 2016-08-09

Last Posted Date: 2021-07-23

Lead Sponsor: Peking University Cancer Hospital & Institute

Target Recruit Count: 68

Registration Number: NCT02860234

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China

A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

Phase 3

Conditions: Pancreatic Cancer

Interventions: Drug: Gemcitabine
Drug: GV1001
Drug: Capecitabine

First Posted Date: 2016-08-03

Last Posted Date: 2016-11-22

Lead Sponsor: Samsung Pharmaceutical Co., Ltd.

Target Recruit Count: 148

Registration Number: NCT02854072

Locations: 🇰🇷
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
🇰🇷
Gangnam Severance Hospital, Seoul, Korea, Republic of
🇰🇷
Jeju National University Hospital, Jeju-si, Jeju-do, Korea, Republic of

and more 13 locations

To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: 5-Fluorouracil
Drug: Capecitabine
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Epirubicin

First Posted Date: 2016-07-27

Last Posted Date: 2016-07-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 182

Registration Number: NCT02846428

De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Neoplasms

Interventions: Drug: 5 FLUOROURACYL
Drug: acide folinique
Drug: irinotecan
Drug: Oxaliplatin
Drug: capécitabine
Drug: bevacizumab

First Posted Date: 2016-07-25

Last Posted Date: 2024-07-10

Lead Sponsor: Federation Francophone de Cancerologie Digestive

Target Recruit Count: 21

Registration Number: NCT02842580

Locations: 🇫🇷
CHU Robert DEBRE, Reims, France
🇫🇷
Ch de Cholet - Service Maladies de L4Appareil Digestif Du Dr Kaasis, Cholet, France
🇫🇷
Chd Vendee - Service D'Hge, La Roche-sur-Yon, France

and more 8 locations

X Versus Placebo as Postoperative Adjuvant Treatment for Elder Breast Cancer

Phase 2

Conditions: Breast Cancer

Interventions: Drug: Placebo
Drug: Capecitabine

First Posted Date: 2016-07-20

Last Posted Date: 2016-07-20

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 300

Registration Number: NCT02838238

Locations: 🇨🇳
Dept. Breast Surgery, PUMCH, Beijing, Beijing, China

Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor

Phase 1

Withdrawn

Conditions: Multiple Endocrine Neoplasia Type 1
Functional Pancreatic Neuroendocrine Tumor
Malignant Somatostatinoma
Metastatic Carcinoid Tumor
Multiple Endocrine Neoplasia Type 2A
Stage IIIA Merkel Cell Carcinoma
Stage IIIB Merkel Cell Carcinoma
Stage IVB Thyroid Gland Medullary Carcinoma
VIP-Producing Neuroendocrine Tumor
Merkel Cell Carcinoma

Interventions: Drug: Capecitabine
Drug: Temozolomide
Drug: Veliparib
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis

First Posted Date: 2016-07-13

Last Posted Date: 2017-09-28

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Registration Number: NCT02831179

Clinical Trial of Adjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy Compared With Adjuvant Chemotherapy Alone in Patients With Gallbladder Carcinoma and Extrahepatic Cholangiocarcinoma

Phase 3

Conditions: Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct

Interventions: Radiation: Concurrent Chemoradiotherapy
Drug: capecitabine
Drug: gemcitabine

First Posted Date: 2016-06-14

Last Posted Date: 2016-06-22

Lead Sponsor: Fudan University

Target Recruit Count: 140

Registration Number: NCT02798510

Locations: 🇨🇳
Fudan university cancer hospital, Shanghai, Shanghai, China

Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

Phase 1

Completed

Conditions: Advanced/Metastatic Tumors

Interventions: Drug: Tiragolumab
Drug: Atezolizumab
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Capecitabine
Drug: Bevacizumab
Drug: Cisplatin
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Etoposide

First Posted Date: 2016-06-09

Last Posted Date: 2024-12-05

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 518

Registration Number: NCT02794571

Locations: 🇰🇷
Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of
🇺🇸
Henry Ford Hospital, Detroit, Michigan, United States
🇺🇸
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 25 locations

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