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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

Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer

Phase 2
Completed
Conditions
Stage III Rectal Cancer AJCC v7
Rectal Adenocarcinoma
Stage II Rectal Cancer AJCC v7
Interventions
Drug: Capecitabine
Drug: Fluorouracil
Radiation: Intensity-Modulated Radiation Therapy
Drug: Leucovorin
Drug: Oxaliplatin
Biological: Pembrolizumab
Drug: Veliparib
First Posted Date
2016-10-03
Last Posted Date
2024-04-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
363
Registration Number
NCT02921256
Locations
🇺🇸

Island Urology, Honolulu, Hawaii, United States

🇺🇸

Queen's Medical Center, Honolulu, Hawaii, United States

🇺🇸

Straub Clinic and Hospital, Honolulu, Hawaii, United States

and more 645 locations

Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced Rectal Cancer

Phase 2
Conditions
Rectal Adenocarcinoma
Interventions
First Posted Date
2016-09-29
Last Posted Date
2018-08-13
Lead Sponsor
King Faisal Specialist Hospital & Research Center
Target Recruit Count
25
Registration Number
NCT02919878
Locations
🇸🇦

Oncology Centre, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia

Lenvatinib and Capecitabine in Patients With Advanced Malignancies

Phase 1
Withdrawn
Conditions
Malignant Neoplasm of Breast
Malignant Neoplasms of Digestive Organs
Malignant Neoplasms of Mesothelial and Soft Tissue
Advanced Cancer
Malignant Neoplasms of Bone and Articular Cartilage
Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
Malignant Neoplasms of Female Genital Organs
Malignant Neoplasms of Independent (Primary) Multiple Sites
Malignant Neoplasms of Urinary Tract
Malignant Neoplasms of Lip Oral Cavity and Pharynx
Interventions
First Posted Date
2016-09-26
Last Posted Date
2017-06-26
Lead Sponsor
M.D. Anderson Cancer Center
Registration Number
NCT02915172

Neoadjuvant Treatment With Regorafenib and Capecitabine Combined With Radiotherapy in Locally Advanced Rectal Cancer

Phase 1
Terminated
Conditions
Rectal Cancer
Interventions
Drug: Regorafenib
Drug: Capecitabine
Radiation: Radiotherapy
Procedure: Surgery
First Posted Date
2016-09-22
Last Posted Date
2023-01-10
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
25
Registration Number
NCT02910843
Locations
🇨🇭

St. Claraspital Basel, Basel, Switzerland

🇨🇭

Universitätsspital Basel, Basel, Switzerland

🇨🇭

Inselspital Bern, Bern, Switzerland

and more 4 locations

Pembrolizumab, Trastuzumab, HER2 Positive Gastric Cancer

First Posted Date
2016-09-15
Last Posted Date
2021-04-06
Lead Sponsor
Yonsei University
Target Recruit Count
41
Registration Number
NCT02901301
Locations
🇰🇷

Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of

Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer

First Posted Date
2016-09-12
Last Posted Date
2022-04-20
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
170
Registration Number
NCT02897050
Locations
🇨🇳

Second Xiangya Hospital of Central South University, Changsha, Hunan, China

🇨🇳

Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, China

🇨🇳

Peking University Shenzhen Hospital, Shenzhen, Guangdong, China

and more 1 locations

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

Phase 1
Completed
Conditions
HER2-expressing Cancers
Interventions
First Posted Date
2016-09-08
Last Posted Date
2024-11-27
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
279
Registration Number
NCT02892123
Locations
🇺🇸

Hoag Family Cancer Institute, Newport Beach, California, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

and more 14 locations

Metronomic Versus Conventional Chemotherapy in as Maintenance Treatment in mCRC

Phase 2
Conditions
Colorectal Cancer
Interventions
First Posted Date
2016-09-08
Last Posted Date
2016-09-16
Lead Sponsor
Ruijin Hospital
Target Recruit Count
250
Registration Number
NCT02893540
Locations
🇨🇳

Shanghai Rui Jin Hospital, Shanghai, Shanghai, China

Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer

Phase 2
Completed
Conditions
Recurrent Colorectal Carcinoma
Stage IV Colorectal Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7
Stage IVB Colorectal Cancer AJCC v7
Metastatic Colorectal Carcinoma
Refractory Colorectal Carcinoma
Interventions
Drug: Atezolizumab
Biological: Bevacizumab
Drug: Capecitabine
Other: Placebo
Other: Laboratory Biomarker Analysis
First Posted Date
2016-08-19
Last Posted Date
2024-08-23
Lead Sponsor
Academic and Community Cancer Research United
Target Recruit Count
133
Registration Number
NCT02873195
Locations
🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

and more 7 locations

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

Phase 3
Completed
Conditions
Gastric Cancer
Gastroesophageal Junction Cancer
Esophageal Adenocarcinoma
Interventions
First Posted Date
2016-08-19
Last Posted Date
2024-07-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
2031
Registration Number
NCT02872116
Locations
🇯🇵

Local Institution - 0122, Minato-ku, Tokyo, Japan

🇬🇷

Local Institution - 0017, Nea Kifissia, Attikí, Greece

🇵🇱

Local Institution - 0016, Lublin, Poland

and more 176 locations
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