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

BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study

Phase 1

Terminated

Conditions: Rectal Cancer

Interventions: Drug: BYL719
Drug: Capecitabine
Radiation: Radiation

First Posted Date: 2015-09-15

Last Posted Date: 2021-03-12

Lead Sponsor: howard safran

Target Recruit Count: 7

Registration Number: NCT02550743

Locations: 🇺🇸
Rhode Island Hospital and The Miriam Hospital, Providence, Rhode Island, United States

Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

Phase 3

Conditions: Cholangiocarcinoma

Interventions: Drug: oxaliplatin and gemcitabine
Drug: capecitabine

First Posted Date: 2015-09-14

Last Posted Date: 2015-09-14

Lead Sponsor: Shanghai Zhongshan Hospital

Target Recruit Count: 286

Registration Number: NCT02548195

Locations: 🇨🇳
Zhongshan Hospital, Shanghai, Shanghai, China

Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients

Phase 3

Conditions: Anus Neoplasms
Carcinoma, Squamous Cell
Anus Diseases
Neoplasms
Neoplasms, Squamous Cell
Carcinoma

Interventions: Drug: Paclitaxel
Drug: Capecitabine
Drug: Mitomycins
Radiation: Radiotherapy

First Posted Date: 2015-08-18

Last Posted Date: 2021-02-09

Lead Sponsor: Blokhin's Russian Cancer Research Center

Target Recruit Count: 314

Registration Number: NCT02526953

Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 2

Terminated

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Capecitabine
Drug: Docetaxel
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2015-08-14

Last Posted Date: 2023-09-08

Lead Sponsor: University of Nebraska

Target Recruit Count: 14

Registration Number: NCT02524275

Locations: 🇺🇸
Omaha Veterans Administration Medical Center, Omaha, Nebraska, United States
🇺🇸
Faith Regional Health Services Carson Cancer Center, Norfolk, Nebraska, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer

Phase 3

Conditions: HER2-positive Locally Advanced or Metastatic Breast Cancer

Interventions: Drug: Trastuzumab
Drug: Docetaxel
Drug: Pertuzumab
Drug: Paclitaxel
Drug: Nab-paclitaxel
Drug: Vinorelbine
Drug: Eribulin
Drug: Capecitabine
Drug: Gemcitabine

First Posted Date: 2015-08-04

Last Posted Date: 2020-01-07

Lead Sponsor: Japan Breast Cancer Research Group

Target Recruit Count: 370

Registration Number: NCT02514681

Locations: 🇯🇵
Japan Breast Cancer Research Group, Chuo-ku, Nihonbashi, Koami-cho, Tokyo, Japan
🇯🇵
Kumamoto University Hospital, Kumamoto City, Kumamoto, Japan
🇯🇵
Aichi Cancer Center, Chikusa-ku, Aichi, Japan

Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy

Phase 3

Completed

Conditions: Rectal Cancer

Interventions: Radiation: 50 Gy, 2 Gy/session; 25 fractions
Drug: Neoadjuvant chemotherapy Folfirinox, 4 cycles
Procedure: Local excision in good responders
Procedure: Rectal excision in bad responders
Drug: Capecitabine

First Posted Date: 2015-08-03

Last Posted Date: 2024-08-14

Lead Sponsor: University Hospital, Bordeaux

Target Recruit Count: 218

Registration Number: NCT02514278

Locations: 🇫🇷
Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble, La Tronche, France
🇫🇷
Service de Chirurgie Digestive, CHU de Besançon, Besançon, France
🇫🇷
Service de Chirurgie Digestives, Hôpital Européen de Marseille, Marseille, France

and more 26 locations

Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma

Phase 3

Active, not recruiting

Conditions: Rectal Neoplasms

Interventions: Radiation: 3D conformal EBRT
Device: Contact X-ray brachytherapy 50 kV
Drug: Capecitabine

First Posted Date: 2015-07-22

Last Posted Date: 2024-08-28

Lead Sponsor: Centre Antoine Lacassagne

Target Recruit Count: 236

Registration Number: NCT02505750

Locations: 🇫🇷
Centre d'oncologie et de radiothérapie Mâcon, Mâcon, France
🇩🇰
Aarhus University Hospital, Aarhus, Denmark
🇫🇷
Hospices Civils de Lyon - Hôpital de la Croix Rousse, Lyon, France

and more 17 locations

Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)

Phase 3

Completed

Conditions: Gastric Adenocarcinoma

Interventions: Biological: Pembrolizumab
Drug: Cisplatin
Drug: 5-FU
Drug: Placebo
Drug: Capecitabine

First Posted Date: 2015-07-10

Last Posted Date: 2023-04-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 763

Registration Number: NCT02494583

A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Solid Tumor

Interventions: Drug: Capecitabine
Drug: RhuMab 2C4

First Posted Date: 2015-07-10

Last Posted Date: 2015-11-10

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 19

Registration Number: NCT02494596

FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer

Phase 2

Terminated

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Gastric Adenocarcinoma
Gastric Cancer

Interventions: Procedure: surgery
Procedure: FDG-PET
Drug: 5-FU
Drug: docetaxel
Drug: capecitabine
Radiation: 3D-CRT
Drug: Irinotecan
Radiation: IMRT

First Posted Date: 2015-06-30

Last Posted Date: 2019-09-11

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 5

Registration Number: NCT02485834

Locations: 🇺🇸
Regional Hematology and Oncology PA, Newark, Delaware, United States
🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Englewood Hospital and Medical Center, Englewood, New Jersey, United States

and more 68 locations

Drug Development Updates

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