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

Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)

Phase 3

Completed

Conditions: Nasopharyngeal Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Capecitabine
Drug: Gemcitabine
Drug: Docetaxel

First Posted Date: 2015-11-23

Last Posted Date: 2023-07-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 233

Registration Number: NCT02611960

A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer

Phase 2

Completed

Conditions: Nasopharyngeal Cancer

Interventions: Drug: Capecitabine
Drug: Cisplatin

First Posted Date: 2015-11-18

Last Posted Date: 2016-03-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 45

Registration Number: NCT02608073

Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

Phase 3

Conditions: Locally Advanced Rectal Cancer

Interventions: Radiation: Radiation
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Irinotecan

First Posted Date: 2015-11-16

Last Posted Date: 2016-12-07

Lead Sponsor: Fudan University

Target Recruit Count: 360

Registration Number: NCT02605265

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

Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas

Phase 2

Recruiting

Conditions: Pancreatic Cancer

Interventions: Radiation: Proton Radiation
Drug: Capecitabine
Procedure: Surgical resection

First Posted Date: 2015-11-05

Last Posted Date: 2024-06-03

Lead Sponsor: Proton Collaborative Group

Target Recruit Count: 60

Registration Number: NCT02598349

Locations: 🇺🇸
Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, United States
🇺🇸
McLaren Proton Therapy Center, Flint, Michigan, United States
🇺🇸
Inova Schar Cancer Institute, Fairfax, Virginia, United States

and more 1 locations

A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer(Overstep)

Not Applicable

Conditions: Breast Cancer

Interventions: Procedure: endocrine therapy
Drug: Capecitabine

First Posted Date: 2015-11-05

Last Posted Date: 2016-03-29

Lead Sponsor: Zhejiang Cancer Hospital

Target Recruit Count: 132

Registration Number: NCT02597868

Locations: 🇨🇳
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Cisplatin, Carboplatin and Etoposide or Temozolomide and Capecitabine in Treating Patients With Neuroendocrine Carcinoma of the Gastrointestinal Tract or Pancreas That Is Metastatic or Cannot Be Removed by Surgery

Phase 2

Active, not recruiting

Conditions: Gastric Neuroendocrine Carcinoma
Pancreatic Neuroendocrine Carcinoma
Intestinal Neuroendocrine Carcinoma

Interventions: Drug: Carboplatin
Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Drug: Cisplatin
Drug: Temozolomide
Drug: Etoposide

First Posted Date: 2015-11-03

Last Posted Date: 2024-12-10

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 67

Registration Number: NCT02595424

Locations: 🇺🇸
Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States
🇺🇸
Grant Medical Center, Columbus, Ohio, United States
🇺🇸
Doctors Hospital, Columbus, Ohio, United States

and more 668 locations

Capecitabine in Metastatic Breast and GI Cancers

Phase 2

Conditions: Breast Cancer
Gastrointestinal Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2015-11-03

Last Posted Date: 2021-12-20

Lead Sponsor: Qamar Khan

Target Recruit Count: 200

Registration Number: NCT02595320

Locations: 🇺🇸
St. Francis Comprehensive Cancer Center, Topeka, Kansas, United States
🇺🇸
University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States
🇺🇸
University of Kansas Cancer Center - Westwood, Westwood, Kansas, United States

and more 12 locations