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

A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: BBI503
Drug: Pembrolizumab
Drug: Sunitinib
Drug: Capecitabine
Drug: Doxorubicin
Drug: Nivolumab
Drug: Paclitaxel

First Posted Date: 2015-06-26

Last Posted Date: 2023-11-14

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 165

Registration Number: NCT02483247

Locations: 🇺🇸
Indiana University Health Goshen, Goshen, Indiana, United States
🇺🇸
Louisiana State Univesity, New Orleans, Louisiana, United States
🇨🇦
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

and more 5 locations

Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer

Phase 2

Terminated

Conditions: Adenocarcinoma
Carcinoma
Rectal Neoplasms

Interventions: Drug: Capecitabine
Drug: Metformin
Radiation: Radiotherapy
Drug: Placebo

First Posted Date: 2015-06-16

Last Posted Date: 2017-11-28

Lead Sponsor: University of Campinas, Brazil

Target Recruit Count: 3

Registration Number: NCT02473094

Locations: 🇧🇷
Clinical Oncology Department - General Hospital - State University of Campinas (UNICAMP), Campinas, São Paulo, Brazil

A Study of PEP503(Radio-enhancer) With Radiotherapy and Chemotherapy for Patients With Rectal Cancer

Phase 1

Terminated

Conditions: Rectal Cancer

Interventions: Drug: PEP503
Drug: 5-fluorouracil
Drug: capecitabine
Procedure: surgical resection
Radiation: Radiotherapy

First Posted Date: 2015-06-08

Last Posted Date: 2022-01-11

Lead Sponsor: PharmaEngine

Target Recruit Count: 32

Registration Number: NCT02465593

Locations: 🇨🇳
Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan

Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma

Phase 3

Completed

Conditions: Nasopharyngeal Carcinoma

Interventions: Drug: capecitabine
Other: Best supportive care (BSC)

First Posted Date: 2015-06-02

Last Posted Date: 2022-10-28

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 104

Registration Number: NCT02460419

Locations: 🇨🇳
SunYat-senU, Guangzhou, Guangdong, China

Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer

Phase 1

Completed

Conditions: Bile Duct Carcinoma
Recurrent Malignant Solid Neoplasm
Stage IVA Pancreatic Cancer
Recurrent Pancreatic Carcinoma
Stage III Pancreatic Cancer AJCC v6 and v7
Advanced Malignant Solid Neoplasm
Stage IVB Pancreatic Cancer

Interventions: Drug: Afatinib Dimaleate
Drug: Capecitabine
Other: Laboratory Biomarker Analysis

First Posted Date: 2015-05-22

Last Posted Date: 2022-06-07

Lead Sponsor: University of Washington

Target Recruit Count: 41

Registration Number: NCT02451553

Locations: 🇺🇸
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

Phase 3

Active, not recruiting

Conditions: Invasive Breast Carcinoma
Triple-Negative Breast Carcinoma
Progesterone Receptor Negative
Stage II Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIC Breast Cancer
Estrogen Receptor Negative
Stage IIA Breast Cancer
Stage III Breast Cancer

Interventions: Drug: Carboplatin
Drug: Capecitabine
Drug: Cisplatin

First Posted Date: 2015-05-15

Last Posted Date: 2024-07-03

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 415

Registration Number: NCT02445391

Locations: 🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
🇺🇸
UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States

and more 1014 locations

A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab

Phase 1

Conditions: HER2 Positive Metastatic Breast Cancer

Interventions: Drug: Lapatinib
Drug: pyrotinib
Drug: capecitabine

First Posted Date: 2015-04-21

Last Posted Date: 2018-07-09

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 128

Registration Number: NCT02422199

Locations: 🇨🇳
307 Hospital Affiliated to Academy Military Medical Science, Beijing, China
🇨🇳
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

Phase 1

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Clinical Stage III Cutaneous Melanoma AJCC V8
Clinical Stage IV Cutaneous Melanoma AJCC V8
Fallopian Tube Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Metastatic Renal Cell Carcinoma
Ovarian Carcinoma
Pathologic Stage III Cutaneous Melanoma AJCC V8

Interventions: Drug: Carboplatin
Drug: Eribulin
Drug: Fluorouracil
Drug: Paclitaxel
Drug: Cyclophosphamide
Drug: Capecitabine
Biological: Pembrolizumab
Drug: Olaparib
Biological: Nivolumab
Biological: Ipilimumab
Drug: Selinexor
Drug: Doxorubicin
Drug: Topotecan
Drug: Pemetrexed
Drug: Irinotecan Hydrochloride
Drug: Oxaliplatin
Drug: Leucovorin Calcium

First Posted Date: 2015-04-17

Last Posted Date: 2024-05-21

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 221

Registration Number: NCT02419495

Locations: 🇺🇸
MD Anderson in The Woodlands, Conroe, Texas, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
MD Anderson West Houston, Houston, Texas, United States

and more 2 locations