Gemcitabine

Generic Name
Gemcitabine
Brand Names
Gemzar
Drug Type
Small Molecule
Chemical Formula
C9H11F2N3O4
CAS Number
95058-81-4
Unique Ingredient Identifier
B76N6SBZ8R
Background

Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells. The structure, metabolism, and mechanism of action of gemcitabine are similar to cytarabine, but gemcitabine has a wider spectrum of antitumour activity.

Gemcitabine is marketed as Gemzar and it is available as intravenous injection. It is approved by the FDA to treat advanced ovarian cancer in combination with carboplatin, metastatic breast cancer in combination with paclitaxel, non-small cell lung cancer in combination with cisplatin, and pancreatic cancer as monotherapy. It is also being investigated in other cancer and tumour types.

Indication

Gemcitabine is a chemotherapeutic agent used as monotherapy or in combination with other anticancer agents.

In combination with carboplatin, it is indicated for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

Gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

In combination with cisplatin, gemcitabine is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). Dual therapy with cisplatin is also used to treat patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder.

Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with fluorouracil.

Associated Conditions
Advanced Ovarian Cancer, Bladder Transitional Cell Carcinoma Stage IV, Carcinoma of the Head and Neck, Cervical Cancer, Cutaneous T-Cell Lymphoma (CTCL), Hodgkins Disease (HD), Mesothelioma, Metastatic Breast Cancer, Pancreatic Adenocarcinoma Locally Advanced, Small Cell Lung Cancer (SCLC), Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer (NSCLC), Stage 4 Pancreatic adenocarcinoma
Associated Therapies
-

ZN-c3 + Gemcitabine in Pancreatic Cancer

First Posted Date
2023-08-29
Last Posted Date
2023-12-20
Lead Sponsor
Brandon Huffman
Target Recruit Count
34
Registration Number
NCT06015659
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers

First Posted Date
2023-08-21
Last Posted Date
2024-07-25
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
27
Registration Number
NCT06001658
Locations
🇺🇸

SKCCC Johns Hopkins, Baltimore, Maryland, United States

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

First Posted Date
2023-08-21
Last Posted Date
2024-12-06
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
105
Registration Number
NCT05999994
Locations
🇧🇪

UCL- Saint Luc, Bruxelles, Belgium

🇫🇷

Institut Curie, Paris, France

🇳🇱

Prinses Maxima Centrum, Utrecht, Netherlands

and more 63 locations

A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer

First Posted Date
2023-08-09
Last Posted Date
2024-06-26
Lead Sponsor
NYU Langone Health
Target Recruit Count
10
Registration Number
NCT05984602
Locations
🇺🇸

NYU Langone Ambulatory Care Center East 38th Street, New York, New York, United States

🇺🇸

Ambulatory Care Center, New York, New York, United States

🇺🇸

Clinical Cancer Center, New York, New York, United States

Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer

First Posted Date
2023-08-07
Last Posted Date
2023-08-07
Lead Sponsor
West China Hospital
Target Recruit Count
65
Registration Number
NCT05978609
Locations
🇨🇳

West China Hospital, Sichuan University, Chengdu, Sichuan, China

Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

First Posted Date
2023-08-07
Last Posted Date
2023-08-07
Lead Sponsor
CureLab Oncology
Target Recruit Count
40
Registration Number
NCT05979298
Locations
🇧🇾

Minsk City Clinical Oncology Center, Minsk, Belarus

Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation

First Posted Date
2023-08-03
Last Posted Date
2023-12-19
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
64
Registration Number
NCT05975307
Locations
🇨🇳

Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, China

A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma

First Posted Date
2023-08-01
Last Posted Date
2024-03-21
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
24
Registration Number
NCT05967182
Locations
🇺🇸

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

Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation

First Posted Date
2023-06-26
Last Posted Date
2024-01-24
Lead Sponsor
Hummingbird Bioscience
Target Recruit Count
68
Registration Number
NCT05919537
Locations
🇦🇺

ICON Cancer Centre South Brisbane, Brisbane, Queensland, Australia

🇦🇺

GenesisCare North Shore, Sydney, New South Wales, Australia

🇦🇺

Southern Oncology Clinical Research Unit, Adelaide, South Australia, Australia

and more 2 locations
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