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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

Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Phase 2
Recruiting
Conditions
Rectal Cancer
Interventions
Drug: Capecitabine
Radiation: Radiation therapy
Drug: mFOLFOX6
Drug: Nivolumab
First Posted Date
2019-04-19
Last Posted Date
2019-04-19
Lead Sponsor
Baruch Brenner
Target Recruit Count
29
Registration Number
NCT03921684
Locations
🇮🇱

Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel

Chemoradiation With Enadenotucirev as a Radiosensitiser in Locally Advanced Rectal Cancer

Phase 1
Completed
Conditions
Locally Advanced Rectal Cancer
Interventions
Biological: Enadenotucirev
Drug: Capecitabine
Radiation: Radiotherapy
First Posted Date
2019-04-16
Last Posted Date
2023-06-28
Lead Sponsor
University of Oxford
Target Recruit Count
13
Registration Number
NCT03916510
Locations
🇬🇧

Velindre Cancer Centre, Cardiff, United Kingdom

🇬🇧

Royal Marsden NHS Foundation Trust, London Borough of Sutton, United Kingdom

🇬🇧

Beatson West Of Scotland Cancer Centre, Glasgow, United Kingdom

and more 1 locations

Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, (DURVA+ Study)

Phase 2
Recruiting
Conditions
Metastatic Malignant Solid Neoplasm
Locally Advanced Malignant Solid Neoplasm
Interventions
Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Capecitabine
Drug: Carboplatin
Procedure: Computed Tomography
Biological: Durvalumab
Drug: Gemcitabine Hydrochloride
Procedure: Echocardiography
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
First Posted Date
2019-04-09
Last Posted Date
2024-08-22
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
115
Registration Number
NCT03907475
Locations
🇺🇸

National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland, United States

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

First Posted Date
2019-04-03
Last Posted Date
2024-10-21
Lead Sponsor
Gilead Sciences
Target Recruit Count
543
Registration Number
NCT03901339
Locations
🇺🇸

The University of Kansas Cancer Center, Westwood, Kansas, United States

🇺🇸

University of Chicago Medical Center, Chicago, Illinois, United States

🇺🇸

Maryland Oncology Hematology, P.A., Rockville, Maryland, United States

and more 110 locations

Pan Tumor Rollover Study

First Posted Date
2019-04-02
Last Posted Date
2025-01-07
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
1500
Registration Number
NCT03899155
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

🇨🇦

Local Institution - 0040, Montreal, Quebec, Canada

🇨🇦

Local Institution - 0308, Montreal, Quebec, Canada

and more 304 locations

The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

Phase 3
Conditions
Capecitabine
Molecular Mechanisms of Pharmacological Action
Stomach Neoplasms
Digestive System Neoplasms
Apatinib
Stomach Diseases
Gastrointestinal Neoplasms
Neoplasms
Interventions
First Posted Date
2019-03-26
Last Posted Date
2019-03-26
Lead Sponsor
Fudan University
Target Recruit Count
242
Registration Number
NCT03889626

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1
Terminated
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma
Interventions
First Posted Date
2019-03-18
Last Posted Date
2024-03-04
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
2
Registration Number
NCT03878524
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy

Phase 2
Terminated
Conditions
Anatomic Stage III Breast Cancer AJCC v8
HER2/Neu Negative
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Inflammatory Breast Carcinoma
Estrogen Receptor Negative
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Progesterone Receptor Negative
Prognostic Stage IIB Breast Cancer AJCC v8
Interventions
First Posted Date
2019-03-13
Last Posted Date
2024-10-02
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
6
Registration Number
NCT03872388
Locations
🇺🇸

Banner - MD Anderson Cancer Center -Northern Colorado, Greeley, Colorado, United States

🇺🇸

Cooper Hospital University Medical Center, Camden, New Jersey, United States

🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

and more 2 locations

A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients

Phase 2
Conditions
Biliary Tract Cancer
Interventions
First Posted Date
2019-03-13
Last Posted Date
2020-02-13
Lead Sponsor
Hutchison Medipharma Limited
Target Recruit Count
298
Registration Number
NCT03873532
Locations
🇨🇳

PLA 307 Hospital, Beijing, Beijing, China

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