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

Effects of S-1 and Capecitabine on Coronary Artery Blood Flow

Phase 2

Terminated

Conditions: Rectum Cancer
Esophagus Cancer
Stomach Cancer
Small Bowel Cancer
Colon Cancer

Interventions: Drug: S-1
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2014-08-13

Last Posted Date: 2018-08-28

Lead Sponsor: Heikki Joensuu

Target Recruit Count: 20

Registration Number: NCT02216149

Locations: 🇫🇮
Helsinki University Central Hospital, Helsinki, Finland

MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients

Phase 2

Terminated

Conditions: Breast Cancer
HER2 Positive Breast Cancer

Interventions: Drug: MM-302
Drug: Gemcitabine
Drug: Trastuzumab
Drug: Capecitabine
Drug: Vinorelbine

First Posted Date: 2014-08-11

Last Posted Date: 2017-01-06

Lead Sponsor: Merrimack Pharmaceuticals

Target Recruit Count: 113

Registration Number: NCT02213744

Locations: 🇺🇸
Tennessee Oncology, Chattanooga, Tennessee, United States
🇺🇸
Texas Oncology- Medical City, Dallas, Texas, United States
🇺🇸
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

and more 103 locations

Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).

Phase 1

Completed

Conditions: Metastatic Breast Cancer
Pancreatic Cancer
Metastatic Colorectal Cancer

Interventions: Drug: lurbinectedin (PM01183)
Drug: capecitabine

First Posted Date: 2014-08-06

Last Posted Date: 2016-12-14

Lead Sponsor: PharmaMar

Target Recruit Count: 81

Registration Number: NCT02210364

Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

Phase 2

Conditions: Esophageal Neoplasms
Stomach Neoplasms

Interventions: Drug: Carboplatin
Drug: Docetaxel
Drug: Epirubicin
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2014-06-27

Last Posted Date: 2019-02-15

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 98

Registration Number: NCT02177552

Locations: 🇩🇰
Finsen Center, Rigshospitalet, Copenhagen, Denmark

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

Phase 3

Active, not recruiting

Conditions: Gall Bladder Carcinoma
Cholangiocarcinoma

Interventions: Drug: Gemcitabine
Drug: Capecitabine
Drug: Cisplatin

First Posted Date: 2014-06-23

Last Posted Date: 2023-12-05

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Target Recruit Count: 789

Registration Number: NCT02170090

Locations: 🇦🇺
Bankstown Hospital, Bankstown, New South Wales, Australia
🇦🇺
Nepean Hospital Cancer Care, Kingswood, New South Wales, Australia
🇦🇺
St. George Hospital, Kogarah, New South Wales, Australia

and more 62 locations

A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer

Phase 3

Terminated

Conditions: Gastric Cancer

Interventions: Drug: Placebo
Drug: Rilotumumab
Drug: Cisplatin
Drug: Capecitabine

First Posted Date: 2014-05-13

Last Posted Date: 2016-04-04

Lead Sponsor: Amgen

Target Recruit Count: 34

Registration Number: NCT02137343

Locations: 🇰🇷
Research Site, Seoul, Korea, Republic of

Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM

Phase 3

Suspended

Conditions: Colorectal Neoplasm
Effects of Radiation Therapy
Effects of Chemotherapy
Surgery

Interventions: Procedure: Rectectomy
Radiation: Radiotherapy
Drug: Capecitabine
Drug: Oxaliplatin

First Posted Date: 2014-04-23

Last Posted Date: 2022-05-11

Lead Sponsor: Zhejiang University

Target Recruit Count: 350

Registration Number: NCT02121405

Locations: 🇨🇳
Union Hospital Fujian Medical University, Fuzhou, Fujian, China
🇨🇳
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
🇨🇳
Liaoning Cancer Hospital, Shenyang, Liaoning, China

and more 4 locations