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

Tucatinib Together With Pembrolizumab and Trastuzumab

Phase 2

Recruiting

Conditions: Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: Tucatinib
Drug: Pembrolizumab
Drug: Trastuzumab
Drug: Capecitabine

First Posted Date: 2021-03-09

Last Posted Date: 2024-06-21

Lead Sponsor: Breast Cancer Trials, Australia and New Zealand

Target Recruit Count: 57

Registration Number: NCT04789096

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
🇦🇺
Macquarie University, Macquarie Park, New South Wales, Australia
🇦🇺
Nepean Cancer Care Centre, Kingswood, New South Wales, Australia

and more 12 locations

Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)

Phase 3

Recruiting

Conditions: Gastric Cancer

Interventions: Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2021-03-08

Last Posted Date: 2022-02-21

Lead Sponsor: Hallym University Medical Center

Target Recruit Count: 976

Registration Number: NCT04787354

Locations: 🇰🇷
Hallym University Medical Center, Gyeonggi-do, Korea, Republic of

Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence

Phase 1

Conditions: Cholangiocarcinoma, Intrahepatic

Interventions: Drug: Capecitabine
Drug: PD-1 Antibody（Tislelizumab）

First Posted Date: 2021-03-04

Last Posted Date: 2022-08-18

Lead Sponsor: Fudan University

Target Recruit Count: 30

Registration Number: NCT04782804

Locations: 🇨🇳
Lulu@Huashan.Org.Cn, Shanghai, China

Albumin-bound Paclitaxel Combination With Capecitabine Versus Capecitabine Monotherapy in Paclitaxel/Docetaxel-resistant Advanced Breast Cancer

Phase 2

Conditions: Breast Cancer

Interventions: Drug: Albumin-bound paclitaxel plus capecitabine
Drug: capecitabine

First Posted Date: 2021-03-03

Last Posted Date: 2021-03-03

Lead Sponsor: Fudan University

Target Recruit Count: 92

Registration Number: NCT04780347

Locations: 🇨🇳
Fudan University Shanghai Cancer center, Shanghai, China

Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer

Phase 2

Recruiting

Conditions: Triple Negative Breast Cancer
Breast Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2021-02-24

Last Posted Date: 2024-02-22

Lead Sponsor: Stanford University

Target Recruit Count: 25

Registration Number: NCT04768426

Locations: 🇺🇸
Stanford University, Stanford, California, United States

Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.

Phase 2

Recruiting

Conditions: Metastatic Pancreatic Cancer

Interventions: Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Cisplatin
Drug: Irinotecan
Drug: Capecitabine
Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2021-02-15

Last Posted Date: 2024-08-23

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 38

Registration Number: NCT04753879

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Guided Treatment Based on Mini-PDX in Metastatic Triple Negative Breast Cancer

Phase 2

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Nab paclitaxel
Drug: Personalized treatment guided by mini-PDX and RNA sequencing
Drug: Eribulin
Drug: Vinorelbine
Drug: Gemcitabine
Drug: Capecitabine

First Posted Date: 2021-02-09

Last Posted Date: 2022-04-20

Lead Sponsor: Fudan University

Target Recruit Count: 100

Registration Number: NCT04745975

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Tucatinib
Biological: Trastuzumab
Drug: Capecitabine

First Posted Date: 2021-01-25

Last Posted Date: 2024-08-09

Lead Sponsor: Pfizer

Target Recruit Count: 66

Registration Number: NCT04721977

Locations: 🇰🇷
Seoul National University Hospital ( Site 2003), Seoul, Korea, Republic of
🇯🇵
National Cancer Center Hospital ( Site 1003), Tokyo, Japan
🇯🇵
Fukushima Medical University Hospital ( Site 1012), Fukushima, Japan

and more 25 locations