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 Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Phase 1

Recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Capecitabine
Drug: Atezolizumab
Drug: Ribociclib (dose #1)
Drug: Inavolisib (dose #2)
Drug: Abemaciclib
Drug: Trastuzumab Deruxtecan
Drug: Ipatasertib
Drug: Sacituzumab Govitecan
Drug: Fulvestrant
Drug: Ribociclib (dose #2)
Drug: Inavolisib (dose #1)
Drug: SGN-LIV1A
Drug: Chemotherapy (Gemcitabine + Carboplatin or Eribulin)
Drug: Tocilizumab
Drug: Bevacizumab
Drug: Letrozole
Drug: Nab-Paclitaxel
Drug: Inavolisib
Drug: Selicrelumab

First Posted Date: 2018-02-06

Last Posted Date: 2025-01-10

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 580

Registration Number: NCT03424005

Locations: 🇺🇸
University of California San Diego Medical Center, La Jolla, California, United States
🇺🇸
Hackensack Univ Medical Center, Hackensack, New Jersey, United States
🇺🇸
NYU Langone Medical Center, New York, New York, United States

and more 36 locations

Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy

Phase 3

Recruiting

Conditions: Rectal Neoplasms

Interventions: Drug: mFOLFOX6 or CAPOX
Drug: Capecitabine

First Posted Date: 2018-01-30

Last Posted Date: 2018-11-06

Lead Sponsor: LI XIN-XIANG

Target Recruit Count: 764

Registration Number: NCT03415763

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)

Phase 3

Active, not recruiting

Conditions: Gastric Cancer

Interventions: Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2018-01-16

Last Posted Date: 2024-03-12

Lead Sponsor: Fudan University

Target Recruit Count: 1032

Registration Number: NCT03399110

Locations: 🇨🇳
Anhui Provincial Hospital, Hefei, Anhui, China
🇨🇳
First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
🇨🇳
Shenzhen People's Hospital, Shenzhen, Guangdong, China

and more 6 locations

Pembrolizumab, Capecitabine, and Bevacizumab in Treating Patients With Microsatellite Stable Colorectal Cancer That Is Locally Advanced, Metastatic, or Cannot Be Removed by Surgery

Phase 2

Completed

Conditions: Stage IIIB Colorectal Cancer AJCC v7
Stage IIIC Colorectal Cancer AJCC v7
Stage IV Colorectal Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7
Microsatellite Stable
Stage III Colorectal Cancer AJCC v7
Mismatch Repair Protein Proficient
Stage IVB Colorectal Cancer AJCC v7

Interventions: Biological: Bevacizumab
Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab

First Posted Date: 2018-01-11

Last Posted Date: 2024-03-07

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 44

Registration Number: NCT03396926

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas

Phase 2

Conditions: Neuroendocrine Carcinoma

Interventions: Drug: CPT-11
Drug: Capecitabine
Drug: Calcio levofolinate
Drug: Temozolomide
Drug: 5-Fluorouracil

First Posted Date: 2018-01-02

Last Posted Date: 2021-02-26

Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Target Recruit Count: 112

Registration Number: NCT03387592

Locations: 🇮🇹
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, FC, Italy
🇮🇹
Azienda Ospedaliera-Universitaria di Modena, Modena, MO, Italy
🇮🇹
Ospedale Civile degli Infermi, Faenza, RA, Italy

and more 20 locations

QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed

Phase 1

Terminated

Conditions: Squamous Cell Carcinoma

Interventions: Drug: Aldoxorubicin HCl
Biological: ETBX-011
Biological: ETBX-021
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-4000
Biological: GI-6207
Biological: GI-6301
Biological: haNK for infusion
Drug: Avelumab
Drug: bevacizumab
Drug: Capecitabine
Drug: Cetuximab
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Fluorouracil
Drug: Leucovorin
Drug: nab-Paclitaxel
Drug: Necitumumab
Procedure: SBRT
Biological: N-803

First Posted Date: 2017-12-29

Last Posted Date: 2024-08-05

Lead Sponsor: ImmunityBio, Inc.

Target Recruit Count: 4

Registration Number: NCT03387111

Locations: 🇺🇸
Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States

QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.

Phase 1

Terminated

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Aldoxorubicin HCl
Biological: N-803
Biological: ETBX-011
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-4000
Biological: GI-6207
Biological: GI-6301
Biological: haNK for Infusion
Biological: avelumab
Biological: bevacizumab
Drug: Capecitabine
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: nab-Paclitaxel
Procedure: SBRT