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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

Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer

Phase 1
Terminated
Conditions
Locally Advanced Rectal Adenocarcinoma
Stage IVA Rectal Cancer AJCC v7
Stage IIIA Rectal Cancer AJCC v7
Stage IIIB Rectal Cancer AJCC v7
Stage IV Rectal Cancer AJCC v7
Stage IVB Rectal Cancer AJCC v7
Metastatic Rectal Adenocarcinoma
Rectal Adenocarcinoma
Stage III Rectal Cancer AJCC v7
Stage IIIC Rectal Cancer AJCC v7
Interventions
Drug: Capecitabine
Drug: Fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
Radiation: Radiation Therapy
Biological: Talimogene Laherparepvec
First Posted Date
2017-10-03
Last Posted Date
2024-05-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
3
Registration Number
NCT03300544
Locations
🇺🇸

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

Safety, Tolerability and Pharmacokinetics of Oral Tablet of Irinotecan in Adult Patients With Solid Tumors

Phase 1
Completed
Conditions
Metastatic Colorectal Cancer
Interventions
First Posted Date
2017-09-27
Last Posted Date
2020-10-05
Lead Sponsor
Dorte Nielsen
Target Recruit Count
39
Registration Number
NCT03295084
Locations
🇩🇰

Herlev Hospital, Herlev, Denmark

NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer

Phase 2
Recruiting
Conditions
Colorectal Neoplasm
Colorectal Cancer
Rectal Neoplasms
Chemotherapy Effect
Intestinal Disease
Intestinal Neoplasms
Rectal Cancer
Interventions
Drug: FOLFOX regimen (oxaliplatin/leucovorin/5FU)
Drug: Capecitabine
Drug: CAPOX (oxaliplatin/capecitabine)
First Posted Date
2017-09-12
Last Posted Date
2017-09-28
Lead Sponsor
Zealand University Hospital
Target Recruit Count
124
Registration Number
NCT03280407
Locations
🇩🇰

Vejle Hospital, Vejle, Denmark

Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer

Phase 2
Recruiting
Conditions
Stage II Gastric Cancer AJCC v7
Stage IIIA Gastric Cancer AJCC v7
Stage IIIB Gastric Cancer AJCC v7
Epstein-Barr Virus Positive
Gastric Adenocarcinoma
Mismatch Repair Protein Deficiency
Stage IIA Gastric Cancer AJCC v7
Stage IB Gastric Cancer AJCC v7
Stage IIB Gastric Cancer AJCC v7
Stage III Gastric Cancer AJCC v7
Interventions
Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Radiation: Radiation Therapy
First Posted Date
2017-08-22
Last Posted Date
2023-07-13
Lead Sponsor
Rutgers, The State University of New Jersey
Target Recruit Count
40
Registration Number
NCT03257163
Locations
🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

Montefiore Medical Center, Bronx, New York, United States

Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Metastatic Biliary Tract Cancer

Phase 2
Completed
Conditions
Biliary Tract Cancer
Interventions
First Posted Date
2017-07-27
Last Posted Date
2020-11-19
Lead Sponsor
ASLAN Pharmaceuticals
Target Recruit Count
62
Registration Number
NCT03231176
Locations
🇨🇳

No.81 Hospital of The Chinese People's Liberation Army, Nanjing, China

🇨🇳

There is 22 sites located in other cities of China, including Nanjing, Nanjing, China

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)

Phase 3
Active, not recruiting
Conditions
Gastric Cancer
Gastroesophageal Junction Cancer
Interventions
First Posted Date
2017-07-18
Last Posted Date
2024-10-18
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1007
Registration Number
NCT03221426
Locations
🇺🇸

Fox Chase Cancer Center ( Site 0006), Philadelphia, Pennsylvania, United States

🇨🇦

Cross Cancer Institute ( Site 0033), Edmonton, Alberta, Canada

🇨🇦

Jewish General Hospital ( Site 0034), Montreal, Quebec, Canada

and more 168 locations

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Phase 1
Recruiting
Conditions
Glioma of Brain
Brain Tumor Adult
Cancer
Brain Cancer
Glioblastoma
Brain Tumor
Glioblastoma Multiforme (GBM)
Glioblastoma, Adult
Brain Tumor, Primary
Interventions
First Posted Date
2017-07-11
Last Posted Date
2023-11-08
Lead Sponsor
Northwell Health
Target Recruit Count
67
Registration Number
NCT03213002
Locations
🇺🇸

Lenox Hill Brain Tumor Center, New York, New York, United States

Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer

Phase 2
Conditions
Breast Cancer
Interventions
Drug: Capecitabine
Drug: endocrine therapy
First Posted Date
2017-07-02
Last Posted Date
2017-07-02
Lead Sponsor
Zhejiang Cancer Hospital
Target Recruit Count
132
Registration Number
NCT03204734
Locations
🇨🇳

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy

Phase 1
Withdrawn
Conditions
Urothelial Carcinoma
Interventions
Biological: avelumab
Biological: bevacizumab
Drug: capecitabine
Drug: cisplatin
Drug: cyclophosphamide
Drug: 5Fluorouracil (5-FU)
Drug: fulvestrant
Drug: leucovorin
Drug: nab-paclitaxel
Drug: Lovaza
Radiation: Stereotactic Body Radiation Therapy
Biological: ALT-803
Biological: ETBX-011
Biological: ETBX-021
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-4000
Biological: GI-6207
Biological: GI-6301
Biological: haNK
First Posted Date
2017-06-23
Last Posted Date
2021-03-18
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03197571

QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy

Phase 1
Withdrawn
Conditions
Ovarian Cancer
Interventions
Biological: Avelumab
Biological: Bevacizumab
Drug: Capecitabine
Drug: Cyclophosphamide
Drug: 5-fluorouracil
Drug: Fulvestrant
Drug: Leucovorin
Drug: Paclitaxel
Drug: omega-3 acid ethyl esters
Drug: Oxaliplatin
Radiation: Stereotactic Body Radiation Therapy
Biological: ALT-803
Biological: ETBX-021
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-4000
Biological: GI-6301
Biological: haNK®
First Posted Date
2017-06-23
Last Posted Date
2021-03-18
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03197584
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