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

Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

Phase 1

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Capecitabine
Drug: Neratinib
Behavioral: EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30

First Posted Date: 2017-12-19

Last Posted Date: 2024-04-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 34

Registration Number: NCT03377387

Locations: 🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
🇺🇸
Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
Baptist Alliance - McI, Miami, Florida, United States

and more 7 locations

Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

Phase 1

Terminated

Conditions: Metastatic Colorectal Cancer
Colorectal Adenocarcinoma
Pancreatic Adenocarcinoma
Metastatic Pancreatic Cancer

Interventions: Drug: Durvalumab
Biological: CV301
Drug: Capecitabine
Drug: Bevacizumab

First Posted Date: 2017-12-18

Last Posted Date: 2024-02-05

Lead Sponsor: Georgetown University

Target Recruit Count: 8

Registration Number: NCT03376659

Locations: 🇺🇸
Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

Phase 3

Completed

Conditions: Triple Negative Breast Neoplasms

Interventions: Drug: Placebo
Drug: Atezolizumab
Drug: Gemcitabine
Drug: Capecitabine
Drug: Carboplatin

First Posted Date: 2017-12-13

Last Posted Date: 2024-11-08

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 595

Registration Number: NCT03371017

Locations: 🇩🇪
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, Germany
🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of
🇦🇷
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, Argentina

and more 133 locations

Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical Study

Phase 2

Conditions: Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: Trastuzumab
Drug: Capecitabine
Drug: Oxaliplatin
Radiation: Radiotherapy

First Posted Date: 2017-12-11

Last Posted Date: 2020-02-19

Lead Sponsor: Hebei Medical University

Target Recruit Count: 48

Registration Number: NCT03368131

Locations: 🇨🇳
Fourth Affiliated Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction

Phase 2

Conditions: Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: apatinib
Drug: Capecitabine
Drug: Oxaliplatin
Radiation: Radiotherapy

First Posted Date: 2017-11-22

Last Posted Date: 2020-02-19

Lead Sponsor: Hebei Medical University

Target Recruit Count: 48

Registration Number: NCT03349866

Locations: 🇨🇳
The Fourth Hospital of Hebei Medical University, ShiJiaZhuang, Hebei, China

Two Chemotherapy Regimens Plus or Minus Bevacizumab

Phase 2

Active, not recruiting

Conditions: Pancreatic Cancer

Interventions: Drug: LV5FU2
Drug: Capecitabine
Drug: Streptozocin
Drug: Temozolomide
Drug: Bevacizumab

First Posted Date: 2017-11-22

Last Posted Date: 2024-05-08

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 140

Registration Number: NCT03351296

Locations: 🇫🇷
Gustave Roussy, Villejuif, Val De Marne, France
🇫🇷
CHU de Caen, Caen, Calvados, France
🇫🇷
ICM Val d'Aurelle, Montpellier, Hérault, France

and more 16 locations

QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

Phase 1

Terminated

Conditions: Pancreatic Cancer

Interventions: Biological: ALT-803
Biological: ETBX-011
Biological: GI-4000
Biological: haNK for infusion
Biological: avelumab
Biological: bevacizumab
Drug: Capecitabine
Drug: Cyclophosphamide
Drug: Fluorouracil
Drug: Leucovorin
Drug: nab-Paclitaxel
Drug: lovaza
Drug: Oxaliplatin
Procedure: SBRT

First Posted Date: 2017-11-01

Last Posted Date: 2024-12-12

Lead Sponsor: ImmunityBio, Inc.

Target Recruit Count: 6

Registration Number: NCT03329248

Locations: 🇺🇸
Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States

Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC

Phase 3

Terminated

Conditions: Breast Cancer

Interventions: Drug: Tesetaxel and Capecitabine
Drug: Capecitabine

First Posted Date: 2017-10-31

Last Posted Date: 2021-07-30

Lead Sponsor: Odonate Therapeutics, Inc.

Target Recruit Count: 685

Registration Number: NCT03326674

Locations: 🇺🇸
Cancer Treatment Centers of America - Western Regional Medical Center, Goodyear, Arizona, United States
🇺🇸
Arizona Oncology Associates, P.C. - HOPE, Tucson, Arizona, United States
🇺🇸
Ironwood Cancer and Research Centers, Chandler, Arizona, United States

and more 202 locations

HR+/HER2- Advanced Breast Cancer and Endocrine Resistance

Phase 2

Terminated

Conditions: Breast Cancer Metastatic

Interventions: Drug: Capecitabine
Drug: Palbociclib
Drug: Fulvestrant

First Posted Date: 2017-10-26

Last Posted Date: 2024-03-08

Lead Sponsor: Theodoros Foukakis

Target Recruit Count: 42

Registration Number: NCT03322215

Locations: 🇸🇪
Karolinska University Hospital, Stockholm, Sweden
🇸🇪
Uppsala University Hospital, Uppsala, Sweden
🇬🇧
NHS Grampian, Aberdeen, United Kingdom

and more 6 locations

5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab

Phase 3

Terminated

Conditions: Colorectal Adenocarcinoma
Stage IIIB Colorectal Cancer AJCC v7
Stage IIIC Colorectal Cancer AJCC v7
Stage III Colorectal Cancer AJCC v7
RAS Wild Type
Stage IIIA Colorectal Cancer AJCC v7
Stage IV Colorectal Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7
Stage IVB Colorectal Cancer AJCC v7

Interventions: Biological: Panitumumab
Drug: Oxaliplatin
Drug: Leucovorin Calcium
Drug: Fluorouracil
Other: Quality-of-Life Assessment
Drug: Capecitabine
Other: Laboratory Biomarker Analysis

First Posted Date: 2017-10-03

Last Posted Date: 2020-06-11

Lead Sponsor: University of Southern California

Target Recruit Count: 4

Registration Number: NCT03300609

Locations: 🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

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