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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

QUILT-3.049: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy

Phase 1
Withdrawn
Conditions
Triple Negative Breast Cancer
Interventions
Biological: avelumab
Biological: bevacizumab
Drug: capecitabine
Drug: cisplatin
Drug: cyclophosphamide
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: nab-paclitaxel
Drug: Lovaza
Radiation: Stereotactic Body Radiation Therapy
Biological: ALT-803
Biological: ETBX-011
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-4000
Biological: GI-6207
Biological: GI-6301
Biological: haNK
First Posted Date
2017-06-05
Last Posted Date
2021-03-18
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03175666

QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC

Phase 1
Withdrawn
Conditions
Colorectal Cancer
Interventions
Biological: avelumab
Biological: bevacizumab
Drug: capecitabine
Biological: cetuximab
Drug: Cyclophosphamide
Drug: 5-Fluorouracil (5-FU)
Drug: fulvestrant
Drug: leucovorin
Drug: nab paclitaxel
Biological: nivolumab
Drug: Lovaza
Drug: oxaliplatin
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
2017-05-30
Last Posted Date
2021-03-18
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03169777

QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy

Phase 1
Withdrawn
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
Biological: Avelumab
Biological: Bevacizumab
Drug: Capecitabine
Biological: Cetuximab
Drug: Cisplatin
Drug: cyclophosphamide
Drug: 5-Fluorouracil (5-FU)
Drug: fulvestrant
Drug: leucovorin
Drug: nab-paclitaxel
Biological: nivolumab
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
2017-05-30
Last Posted Date
2021-03-19
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03169764

QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL

Phase 1
Withdrawn
Conditions
Non Hodgkin Lymphoma
Interventions
Biological: avelumab
Biological: bevacizumab
Drug: capecitabine
Drug: cyclophosphamide
Drug: 5-Fluorouracil (5-FU)
Drug: leucovorin
Drug: nab-paclitaxel
Drug: Lovaza
Drug: Oxaliplatin
Drug: rituximab
Radiation: Stereotactic Body Radiation Therapy
Biological: ALT-803
Biological: ETBX-061
Biological: haNK
First Posted Date
2017-05-30
Last Posted Date
2021-03-18
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03169790

QUILT-3.044: NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With PD-1/PD-L1 Inhibitors

Phase 1
Withdrawn
Conditions
Non-small Cell Lung Cancer
Interventions
Biological: avelumab
Biological: Bevacizumab
Drug: Capecitabine
Drug: Cisplatin
Drug: cyclophosphamide
Drug: 5-Fluorouracil (5-FU)
Drug: fulvestrant
Drug: leucovorin
Drug: nab paclitaxel
Biological: nivolumab
Drug: Lovaza
Drug: Oxaliplatin
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
2017-05-30
Last Posted Date
2021-03-19
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03169738

QUILT-3.045: NANT Merkel Cell Carcinoma (MCC) Vaccine: Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After PD-L1 Therapy

Phase 1
Withdrawn
Conditions
Merkel Cell Carcinoma
Interventions
Biological: Avelumab
Biological: Bevacizumab
Drug: Capecitabine
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: 5-fluorouracil
Drug: Leucovorin
Drug: nab-Paclitaxel
Drug: omega-3-acid ethyl esters
Radiation: Stereotactic Body Radiation Therapy
Biological: ALT-803
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-6301
Biological: haNK
First Posted Date
2017-05-25
Last Posted Date
2021-03-19
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03167164

QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy

Phase 1
Withdrawn
Conditions
Melanoma
Interventions
Biological: Avelumab
Biological: Bevacizumab
Drug: Capecitabine
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: 5-fluorouracil
Drug: Leucovorin
Drug: nab-paclitaxel
Biological: Nivolumab
Drug: omega-3-acid ethyl esters
Radiation: Stereotactic Body Radiation Therapy
Biological: ALT-803
Biological: ETBX-011
Biological: ETBX-051
Biological: ETBX-061
Biological: GI-6207
Biological: GI-6301
Biological: haNK
First Posted Date
2017-05-25
Last Posted Date
2021-03-19
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03167177

Chemotherapy with or Without Radiation or Surgery in Treating Participants with Oligometastatic Esophageal or Gastric Cancer

Phase 2
Recruiting
Conditions
Gastric Adenocarcinoma
Oligometastasis
Stage IV Esophageal Adenocarcinoma AJCC V7
Stage IV Esophageal Cancer AJCC V7
Stage IV Gastric Cancer AJCC V7
Interventions
Drug: Capecitabine
Drug: Chemotherapy
Procedure: Conventional Surgery
Drug: Fluorouracil
Radiation: Radiation Therapy
First Posted Date
2017-05-19
Last Posted Date
2024-10-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
100
Registration Number
NCT03161522
Locations
🇺🇸

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

Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Metastatic Colorectal Cancer

Phase 2
Terminated
Conditions
Colorectal Cancer
Interventions
First Posted Date
2017-05-18
Last Posted Date
2021-05-03
Lead Sponsor
Ruijin Hospital
Target Recruit Count
20
Registration Number
NCT03158610
Locations
🇨🇳

Department of Oncology, Ruijin Hospital, Shanghai, China

Preoperative Radiotherapy and E7046 in Rectum Cancer

Phase 1
Completed
Conditions
Neoadjuvant Therapy in Rectal Cancer
Interventions
Drug: E7046
Radiation: Long Course Chemoradiotherapy (LCRT)
Radiation: Short Course Radiotherapy (SCRT)
Drug: folinic acid/5-FU/oxaliplatin (mFOLFOX-6)
Drug: capecitabine
First Posted Date
2017-05-15
Last Posted Date
2021-10-04
Lead Sponsor
Adlai Nortye Biopharma Co., Ltd.
Target Recruit Count
29
Registration Number
NCT03152370
Locations
🇬🇧

The Christie, Manchester, United Kingdom

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Weill Cornell, New York, New York, United States

and more 2 locations
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