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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

Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]

Phase 2
Terminated
Conditions
Colorectal Neoplasms
Interventions
First Posted Date
2016-05-23
Last Posted Date
2018-10-11
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1
Registration Number
NCT02780700
Locations
🇺🇸

Fort Wayne Medical Oncology Hematology, Fort Wayne, Indiana, United States

Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer

Phase 3
Active, not recruiting
Conditions
Breast Cancer
Interventions
Drug: Aromatase Inhibitor
Drug: Capecitabine
First Posted Date
2016-05-10
Last Posted Date
2024-02-16
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
240
Registration Number
NCT02767661
Locations
🇨🇳

State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Gemcitabine and Capecitabine With or Without T-ChOS as Adjuvant Therapy for Patients With Resected Pancreatic Cancer

Phase 2
Terminated
Conditions
Pancreatic Cancer
Interventions
Dietary Supplement: T-ChOS
Dietary Supplement: Placebo
Drug: Gemcitabine
Drug: Capecitabine
First Posted Date
2016-05-10
Last Posted Date
2018-07-10
Lead Sponsor
Herlev Hospital
Target Recruit Count
21
Registration Number
NCT02767752
Locations
🇩🇰

Department of Oncology, Herlev, Denmark

Study of ONO-4538 in Gastric Cancer

Phase 2
Completed
Conditions
Gastric Cancer
Interventions
First Posted Date
2016-04-21
Last Posted Date
2024-05-03
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Target Recruit Count
680
Registration Number
NCT02746796
Locations
🇯🇵

Tokyo Clinical Site2, Shinjuku-ku, Tokyo, Japan

🇨🇳

Tainan Clinical Site1, Tainan, Taiwan

🇨🇳

Tainan Clinical Site2, Tainan, Taiwan

and more 94 locations

Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation

Phase 2
Conditions
Oesophageal Cancer
Interventions
First Posted Date
2016-04-18
Last Posted Date
2018-10-25
Lead Sponsor
Lisette Nixon
Target Recruit Count
584
Registration Number
NCT02741856
Locations
🇬🇧

Bristol Haematology & Oncology, Bristol, United Kingdom

🇬🇧

Aberdeen Royal Infirmary, Aberdeen, United Kingdom

🇬🇧

Velindre Cancer Care Centre, Cardiff, United Kingdom

and more 23 locations

177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors

Phase 2
Conditions
Gastro-entero-pancreatic Neuroendocrine Tumors
Interventions
Drug: Lu-PRRT
Drug: Capecitabine
Drug: SS-LAR
First Posted Date
2016-04-13
Last Posted Date
2021-02-26
Lead Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Target Recruit Count
35
Registration Number
NCT02736448
Locations
🇮🇹

Irst Irccs, Meldola, FC, Italy

Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer

First Posted Date
2016-04-12
Last Posted Date
2024-03-22
Lead Sponsor
Ludwig Institute for Cancer Research
Target Recruit Count
73
Registration Number
NCT02735239
Locations
🇬🇧

Research Facility, Southampton, United Kingdom

Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer

Phase 1
Active, not recruiting
Conditions
Triple Negative Breast Cancer
Interventions
First Posted Date
2016-04-12
Last Posted Date
2024-02-22
Lead Sponsor
Providence Health & Services
Target Recruit Count
29
Registration Number
NCT02734290
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Providence Cancer Center, Portland, Oregon, United States

Phase II Study of Ramucirumab With Chemotherapy in Patients With Metastatic Gastroesophageal Junction and Gastric Cancer

Phase 2
Terminated
Conditions
Gastric Cancer
Gastroesophageal Junction Cancer
Interventions
First Posted Date
2016-04-01
Last Posted Date
2020-01-21
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
7
Registration Number
NCT02726399
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Westchester, Harrison, New York, United States

🇺🇸

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 3 locations

Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)

Phase 2
Completed
Conditions
Secondary
Carcinoma, Hepatocellular
Interventions
First Posted Date
2016-03-23
Last Posted Date
2020-04-10
Lead Sponsor
The University of Hong Kong
Target Recruit Count
46
Registration Number
NCT02716766
Locations
🇭🇰

Queen Mary Hospital, Hong Kong, Hong Kong

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