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Capecitabine

Generic Name
Capecitabine
Brand Names
Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva
Drug Type
Small Molecule
Chemical Formula
C15H22FN3O6
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

QUILT-3.088: NANT Pancreatic Cancer Vaccine

Phase 2
Withdrawn
Conditions
Metastatic Pancreatic Cancer
Interventions
Drug: Gemcitabine
Drug: Aldoxorubicin HCl
Drug: Nab-paclitaxel
Biological: ALT-803
Biological: ETBX-011
Biological: ETBX-021
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-4000
Biological: GI-6207
Biological: GI-6301
Biological: haNK
Drug: Avelumab
Drug: Bevacizumab
Drug: Capecitabine
Drug: Cyclophosphamide
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
First Posted Date
2018-06-20
Last Posted Date
2021-03-18
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03563144
Locations
🇺🇸

Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States

QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

First Posted Date
2018-06-20
Last Posted Date
2024-12-11
Lead Sponsor
ImmunityBio, Inc.
Target Recruit Count
2
Registration Number
NCT03563157
Locations
🇺🇸

Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States

QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine

Phase 1
Withdrawn
Conditions
Hepatocellular Carcinoma Recurrent
Hepatocellular Carcinoma Non-resectable
Interventions
Biological: ETBX-011
Biological: GI-4000
Biological: haNK for infusion
Biological: avelumab
Drug: Capecitabine
Drug: Cyclophosphamide
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: nab-Paclitaxel
Drug: Sorafenib
Procedure: SBRT
Biological: Aldoxorubicin hydrochloride
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-6207
Biological: GI-6301
Drug: Cetuximab
Biological: N-803
First Posted Date
2018-06-20
Last Posted Date
2021-03-18
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03563170
Locations
🇺🇸

Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States

A Study of the Addition of Metronomic Capecitabine to Standard Adjuvant Therapy in High Risk HER2+ BC paTients

Phase 3
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2018-06-19
Last Posted Date
2018-07-26
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
794
Registration Number
NCT03561740
Locations
🇨🇳

Shusen Wang, Guangzhou, Guangdong, China

A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer

Phase 1
Completed
Conditions
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Pancreatic Neoplasms
Digestive System Neoplasm
Adenocarcinoma
Pancreatic Diseases
Neoplasm, Glandular
Neoplasms Pancreatic
Digestive System Disease
Interventions
First Posted Date
2018-05-24
Last Posted Date
2024-12-31
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
48
Registration Number
NCT03535727
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

Phase 3
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2018-05-14
Last Posted Date
2024-11-05
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
608
Registration Number
NCT03523585
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

The Methodist Hospital Research Institute, Houston, Texas, United States

🇧🇪

Az Groeninge, Kortrijk, Belgium

and more 221 locations

Use of High-dose Radiation Therapy Plus Chemotherapy to Improve the Likelihood of Surgical Treatment in Patients With Locally Advanced Pancreatic Cancer

Phase 2
Active, not recruiting
Conditions
Pancreatic Cancer
Interventions
Radiation: Hypofractionated ablative IMRT (HFA-IMRT)
Drug: capecitabine
First Posted Date
2018-05-14
Last Posted Date
2024-05-02
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
47
Registration Number
NCT03523312
Locations
🇺🇸

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 5 locations

Molecular Profile of Breast Cancer in Ugandan Patients With Stage IIB-III Breast Cancer

Phase 1
Completed
Conditions
Anatomic Stage IIIC Breast Cancer AJCC v8
Invasive Breast Carcinoma
Prognostic Stage IIB Breast Cancer AJCC v8
Breast Cancer Female
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Interventions
First Posted Date
2018-05-08
Last Posted Date
2022-06-08
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
100
Registration Number
NCT03518242
Locations
🇺🇬

Uganda Cancer Institute, Kampala, Uganda

🇺🇬

New Mulago Hospital, Kampala, Uganda

Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers

Early Phase 1
Terminated
Conditions
Gastrointestinal Cancer
Interventions
First Posted Date
2018-05-04
Last Posted Date
2020-10-12
Lead Sponsor
Tannaz Armaghany
Target Recruit Count
6
Registration Number
NCT03515941
Locations
🇺🇸

Baylor St. Lukes Medical Center, Houston, Texas, United States

🇺🇸

Baylor College of Medicine Medical Center - McNair Campus, Houston, Texas, United States

🇺🇸

Harris Health System- Smith Clinic, Houston, Texas, United States

and more 1 locations

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Phase 2
Active, not recruiting
Conditions
Breast Neoplasms
Breast Diseases
Capecitabine
HER2-positive Breast Cancer
HER2 Positive Breast Carcinoma
HER2-positive Advanced Breast With Liver Metastases
Interventions
First Posted Date
2018-04-18
Last Posted Date
2024-02-20
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
301
Registration Number
NCT03500380
Locations
🇨🇳

Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China

🇨🇳

Peking University People's Hospital, Beijing, China

🇨🇳

The First Affiliated Hospital of Bengbu Medical College, Bengbu, China

and more 64 locations
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