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 Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases

Phase 2

Withdrawn

Conditions: Malignant Tumor of Pancreas Metastatic to Liver

Interventions: Biological: Anti-CEA CAR-T cells
Drug: NLIR+FU/FA
Drug: gemcitabine/nab paclitaxel
Drug: Capecitabine

First Posted Date: 2019-07-30

Last Posted Date: 2022-04-01

Lead Sponsor: Sorrento Therapeutics, Inc.

Registration Number: NCT04037241

Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis

Phase 2

Completed

Conditions: Esophagogastric Junction
Gastric Adenocarcinoma
Gastric Cancer
Peritoneal Carcinomatosis

Interventions: Drug: Paclitaxel
Drug: Capecitabine
Device: BardPort Titanium Implanted Port with Peritoneal Catheter

First Posted Date: 2019-07-26

Last Posted Date: 2024-10-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT04034251

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Regorafenib and XELOX as 2nd Line Treatment in Metastatic Colorectal Cancer

Phase 1

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Regorafenib
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2019-07-05

Last Posted Date: 2019-07-05

Lead Sponsor: China Medical University, China

Target Recruit Count: 54

Registration Number: NCT04008511

Locations: 🇨🇳
The First Hospital of China Medical University, Shenyang, Liaoning, China

Metronomic Chemotherapy With Capecitabine for Pancreatic Cancer

Phase 2

Conditions: Pancreatic Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2019-05-22

Last Posted Date: 2021-04-30

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 231

Registration Number: NCT03959150

Locations: 🇨🇳
Department of Oncology, Ruijin Hospital, Shanghai, China

Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer

Phase 1

Completed

Conditions: Resistant Breast Cancer
Non-metastatic Invasive Breast Cancer

Interventions: Drug: Capecitabine
Radiation: Radiotherapy

First Posted Date: 2019-05-22

Last Posted Date: 2023-11-27

Lead Sponsor: A Bapsi Chakravarthy, MD

Target Recruit Count: 20

Registration Number: NCT03958721

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Study of Chemotherapy Combination With Autologous Cell Immunotherapy in the Recurrent and Metastatic Colorectal Cancer

Phase 3

Recruiting

Conditions: Colorectal Cancer

Interventions: Drug: Bevacizumab Injection [Avastin]
Drug: Oxaliplatin
Drug: Capecitabine
Biological: PD1-T cells

First Posted Date: 2019-05-15

Last Posted Date: 2023-08-01

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 198

Registration Number: NCT03950154

Locations: 🇨🇳
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China

A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

Interventions: Drug: ZW25 (Zanidatamab)
Drug: Cisplatin
Drug: Capecitabine
Drug: Gemcitabine
Drug: Fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
Drug: Bevacizumab

First Posted Date: 2019-04-29

Last Posted Date: 2024-10-18

Lead Sponsor: Jazz Pharmaceuticals

Target Recruit Count: 74

Registration Number: NCT03929666

Locations: 🇺🇸
Virginia Mason Medical Center, Seattle, Washington, United States
🇺🇸
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 18 locations