MedPath

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
-

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

Phase 3
Active, not recruiting
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2018-02-07
Last Posted Date
2024-12-03
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
797
Registration Number
NCT03425643
Locations
🇺🇸

UPMC Hillman Cancer Centers ( Site 0041), Pittsburgh, Pennsylvania, United States

🇺🇸

PPG-Oncology ( Site 0043), Fort Wayne, Indiana, United States

🇺🇸

Ingalls Memorial Hospital ( Site 0044), Harvey, Illinois, United States

and more 224 locations

The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy

Phase 2
Conditions
Breast Cancer
Chemotherapy Effect
Disease-free Survival
Interventions
First Posted Date
2018-02-06
Last Posted Date
2018-02-06
Lead Sponsor
Zhiyong Yu
Target Recruit Count
200
Registration Number
NCT03423849

AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer

Phase 1
Completed
Conditions
Advanced Solid Tumours
Interventions
First Posted Date
2018-02-05
Last Posted Date
2024-08-21
Lead Sponsor
AstraZeneca
Target Recruit Count
76
Registration Number
NCT03421353
Locations
🇺🇸

Research Site, Fairfax, Virginia, United States

Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)

Phase 1
Completed
Conditions
Pancreatic Adenocarcinoma Resectable
Pancreatic Cancer
Pancreas Cancer
Pancreatic Ductal Adenocarcinoma
Pancreas Metastases
Interventions
First Posted Date
2018-01-25
Last Posted Date
2023-04-18
Lead Sponsor
HonorHealth Research Institute
Target Recruit Count
27
Registration Number
NCT03410030
Locations
🇺🇸

HonorHealth Research Institute, Scottsdale, Arizona, United States

Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer

Phase 2
Active, not recruiting
Conditions
Biliary Tract Neoplasms
Interventions
First Posted Date
2018-01-23
Last Posted Date
2024-07-05
Lead Sponsor
National Health Research Institutes, Taiwan
Target Recruit Count
92
Registration Number
NCT03406299
Locations
🇨🇳

Taiwan Cooperative Oncology Group, National Health Research Institutes, Taipei, Taiwan

Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage

Phase 3
Conditions
Nasopharyngeal Carcinoma
Interventions
Drug: Gemcitabine
Radiation: standard chemoradiotherapy
First Posted Date
2018-01-19
Last Posted Date
2019-07-08
Lead Sponsor
Fudan University
Target Recruit Count
360
Registration Number
NCT03403829
Locations
🇨🇳

Fudan Universtiy Shanghai Cancer Centre, Shanghai, Shanghai, China

Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

Phase 1
Completed
Conditions
Pancreatic Cancer
Cancer
Interventions
First Posted Date
2018-01-18
Last Posted Date
2020-04-22
Lead Sponsor
Albert Einstein College of Medicine
Target Recruit Count
14
Registration Number
NCT03403049
Locations
🇨🇳

Shanghai Proton and Heavy Ion Center, Shanghai, Shanghai, China

🇺🇸

Albert Einstein College of Medicine, Bronx, New York, United States

The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

Phase 3
Conditions
Stage IV, NSCLC
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Interventions
First Posted Date
2018-01-17
Last Posted Date
2020-11-04
Lead Sponsor
University of Turin, Italy
Target Recruit Count
567
Registration Number
NCT03402048
Locations
🇮🇹

Ospedale di Faenza, Faenza, Ravenna, Italy

🇮🇹

AUSL Rimini-Oncologia Medica Cattolica, Cattolica, Rimini, Italy

🇮🇹

AOU Santa Croce e Carle, Cuneo, Italy

and more 25 locations

Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors

Phase 2
Terminated
Conditions
Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers
Interventions
First Posted Date
2017-12-29
Last Posted Date
2023-02-21
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
256
Registration Number
NCT03386721
Locations
🇫🇷

ICM; Medecine B3, Montpellier cedex 5, France

🇬🇧

Christie Hospital Nhs Trust; Medical Oncology, Manchester, United Kingdom

🇹🇷

Adana Baskent University Hospital; Medical Oncology, Adana, Turkey

and more 41 locations

Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

Phase 3
Completed
Conditions
Pancreas Adenocarcinoma
Interventions
First Posted Date
2017-12-19
Last Posted Date
2024-10-31
Lead Sponsor
NovoCure Ltd.
Target Recruit Count
571
Registration Number
NCT03377491
Locations
🇦🇺

St. John of God Murdoch Hospital, Murdoch, Western Australia, Australia

🇦🇺

Monash Medical Centre, Clayton, Australia

🇦🇺

Sydney Adventist Hospital, Wahroonga, Australia

and more 196 locations
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