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 Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

Phase 1

Active, not recruiting

Conditions: GEJ Adenocarcinoma
Cholangiocarcinoma
Gallbladder Carcinoma
Colorectal Carcinoma
Esophageal Adenocarcinoma
Gastric Adenocarcinoma

Interventions: Drug: tucatinib
Drug: trastuzumab
Drug: oxaliplatin
Drug: leucovorin
Drug: fluorouracil
Drug: pembrolizumab
Drug: capecitabine

First Posted Date: 2020-06-12

Last Posted Date: 2024-10-15

Lead Sponsor: Seagen Inc.

Target Recruit Count: 40

Registration Number: NCT04430738

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇯🇵
National Cancer Center Hospital, Chuo-ku, Other, Japan

and more 19 locations

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Phase 2

Active, not recruiting

Conditions: Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: Lenvatinib
Drug: Docetaxel
Biological: Pembrolizumab
Drug: Capecitabine
Drug: Paclitaxel
Drug: Cetuximab

First Posted Date: 2020-06-11

Last Posted Date: 2024-12-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 408

Registration Number: NCT04428151

Locations: 🇺🇸
Rush University Medical Center ( Site 1560), Chicago, Illinois, United States
🇺🇸
Cleveland Clinic Main ( Site 1598), Cleveland, Ohio, United States
🇺🇸
Boston Medical Center ( Site 1605), Boston, Massachusetts, United States

and more 117 locations

The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer

Phase 2

Conditions: Locally Advanced Rectal Cancer

Interventions: Drug: PD-1 antibody
Drug: Capecitabine
Drug: Irinotecan
Radiation: Neoadjuvant Radiotherapy

First Posted Date: 2020-06-02

Last Posted Date: 2020-06-02

Lead Sponsor: Fudan University

Target Recruit Count: 50

Registration Number: NCT04411524

Locations: 🇨🇳
Zhen Zhang, Shanghai, Shanghai, China

The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer

Phase 2

Conditions: Locally Advanced Rectal Cancer

Interventions: Drug: PD-1 antibody
Drug: Capecitabine
Drug: Irinotecan
Radiation: Neoadjuvant Radiotherapy

First Posted Date: 2020-06-02

Last Posted Date: 2020-06-02

Lead Sponsor: Fudan University

Target Recruit Count: 50

Registration Number: NCT04411537

Locations: 🇨🇳
Zhen Zhang, Shanghai, Shanghai, China

Testing the Addition of a Radiation Sensitizing Drug, IPdR, to the Usual Chemotherapy Treatment (Capecitabine) During Radiation Therapy for Rectal Cancer

Phase 1

Terminated

Conditions: Locally Advanced Rectal Carcinoma
Rectal Adenocarcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8

Interventions: Drug: Capecitabine
Radiation: Radiation Therapy
Drug: Ropidoxuridine

First Posted Date: 2020-05-29

Last Posted Date: 2023-10-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT04406857

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Los Angeles County-USC Medical Center, Los Angeles, California, United States
🇺🇸
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

and more 6 locations