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

Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer

Phase 2

Terminated

Conditions: Gastric Cancer

Interventions: Drug: Capecitabine
Drug: Oxaliplatin
Procedure: D2 resection

First Posted Date: 2012-08-15

Last Posted Date: 2022-10-03

Lead Sponsor: Harbin Medical University

Target Recruit Count: 15

Registration Number: NCT01665274

Locations: 🇨🇳
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer

Completed

Conditions: Breast Cancer, Colorectal Cancer, Gastric Cancer

Interventions: Drug: Capecitabine

First Posted Date: 2012-08-14

Last Posted Date: 2016-05-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 563

Registration Number: NCT01664494

A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)

Phase 3

Terminated

Conditions: Metastatic Breast Cancer

Interventions: Drug: S1 generic
Drug: capecitabine

First Posted Date: 2012-08-02

Last Posted Date: 2018-01-23

Lead Sponsor: Fudan University

Target Recruit Count: 386

Registration Number: NCT01655992

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

Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors

Phase 1

Completed

Conditions: Metastatic Breast Cancer
Gastrointestinal Tumors

Interventions: Drug: Sorafenib
Drug: Capecitabine

First Posted Date: 2012-07-16

Last Posted Date: 2016-09-16

Lead Sponsor: Yale University

Target Recruit Count: 24

Registration Number: NCT01640665

Locations: 🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States

A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma

Phase 1

Completed

Conditions: Rectal Adenocarcinoma

Interventions: Radiation: Radiation
Drug: Bavituximab
Drug: Capecitabine

First Posted Date: 2012-07-06

Last Posted Date: 2020-08-20

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 15

Registration Number: NCT01634685

Locations: 🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States

Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

Phase 2

Completed

Conditions: CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
CLDN18.2-positive Gastric Adenocarcinoma
CLDN18.2-positive Adenocarcinoma of Esophagus

Interventions: Drug: epirubicin
Drug: oxaliplatin
Drug: capecitabine
Drug: zolbetuximab

First Posted Date: 2012-06-28

Last Posted Date: 2024-11-13

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 252

Registration Number: NCT01630083

Locations: 🇷🇺
Site RUS009, Kursk, Russian Federation
🇺🇦
Site UKR003, Dnipropetrovsk, Ukraine
🇺🇦
Site UKR007, Kyiv, Ukraine

and more 45 locations

Combination Chemotherapy, Cetuximab and Radiation for Patients With Localized Gastric Cancer

Phase 1

Terminated

Conditions: Gastric Cancer

Interventions: Biological: Cetuximab
Drug: Capecitabine
Drug: Cisplatin

First Posted Date: 2012-06-05

Last Posted Date: 2013-01-09

Lead Sponsor: Dr Anna Dorothea Wagner

Target Recruit Count: 1

Registration Number: NCT01611506

Locations: 🇨🇭
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer

Phase 2

Conditions: Locally Advanced Non-resectable Breast Cancer
Metastatic Breast Cancer

Interventions: Drug: Tesetaxel
Drug: Capecitabine

First Posted Date: 2012-05-31

Last Posted Date: 2012-06-01

Lead Sponsor: Genta Incorporated

Target Recruit Count: 213

Registration Number: NCT01609127

Locations: 🇺🇸
The West Clinic, Memphis, Tennessee, United States

FOLFIRINOX + RT for Pancreatic Cancer

Phase 2

Conditions: Pancreatic Cancer

Interventions: Drug: FOLFIRINOX
Drug: Capecitabine
Radiation: Short Course Radiation
Procedure: Surgery

First Posted Date: 2012-05-04

Last Posted Date: 2021-05-28

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 48

Registration Number: NCT01591733

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

A Clinical Study Conducted in Multiple Centers Evaluating Escalating Doses of Veliparib in Combination With Capecitabine and Radiation in Patients With Locally Advanced Rectal Cancer

Phase 1

Completed

Conditions: Locally Advanced Rectal Cancer

Interventions: Drug: veliparib
Drug: capecitabine
Radiation: radiation

First Posted Date: 2012-05-02

Last Posted Date: 2017-11-20

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Target Recruit Count: 32

Registration Number: NCT01589419

Locations: 🇺🇸
Site Reference ID/Investigator# 99095, Scottsdale, Arizona, United States
🇺🇸
Site Reference ID/Investigator# 68045, Durham, North Carolina, United States
🇦🇺
Site Reference ID/Investigator# 67882, East Melbourne, Australia

and more 3 locations

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