Gemcitabine

Generic Name: Gemcitabine

Brand Names: Gemzar

Drug Type: Small Molecule

Chemical Formula: C_₉H_₁₁F_₂N_₃O_₄

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: -

Clinical Trials

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Phase 2

Active, not recruiting

Conditions: Cancer of Unknown Primary Site

Interventions: Drug: Alectinib
Drug: Vismodegib
Drug: Carboplatin
Drug: Ipatasertib
Drug: Olaparib
Drug: Erlotinib
Drug: Cisplatin
Drug: Bevacizumab
Drug: Gemcitabine
Drug: Vemurafenib
Drug: Cobimetinib
Drug: Trastuzumab Subcutaneous (SC)
Drug: Pertuzumab
Drug: Atezolizumab
Drug: Paclitaxel
Drug: Entrectinib
Drug: Ivosidenib
Drug: Pemigatinib

First Posted Date: 2018-04-13

Last Posted Date: 2024-06-14

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 528

Registration Number: NCT03498521

Locations: 🇦🇺
Northern Cancer Institute, St Leonards, New South Wales, Australia
🇦🇺
Blacktown Hospital, Blacktown, New South Wales, Australia
🇫🇮
Helsinki University Central Hospital; Dept of Oncology, Helsinki, Finland

and more 134 locations

BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Phase 1

Completed

Conditions: Pancreatic Ductal Adenocarcinoma

Interventions: Drug: BMS-813160
Drug: Nab-paclitaxel
Drug: Nivolumab
Drug: Gemcitabine
Procedure: Biopsy
Procedure: Peripheral blood

First Posted Date: 2018-04-12

Last Posted Date: 2024-08-29

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 40

Registration Number: NCT03496662

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Study of Brentuximab Vedotin in Patients With R/R PTCL Treated With Gemcitabine

Phase 2

Completed

Conditions: Relapsed Peripheral T-Cell Lymphoma
Refractory Peripheral T-Cell Lymphoma

Interventions: Drug: Brentuximab Vedotin - induction
Drug: Gemcitabine
Drug: Brentuximab Vedotin - maintenance
Procedure: autologous or allogeneic stem cell transplantation

First Posted Date: 2018-04-12

Last Posted Date: 2023-01-10

Lead Sponsor: The Lymphoma Academic Research Organisation

Target Recruit Count: 71

Registration Number: NCT03496779

Locations: 🇫🇷
CH Côte Basque, Bayonne, France
🇫🇷
CH Chambéry, Chambery, France
🇫🇷
CHU de Limoges, Limoges, France

and more 36 locations

PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma

Phase 2

Terminated

Conditions: Non-hodgkin Lymphoma,B Cell
Refractory Diffuse Large B-Cell Lymphoma
Relapsed Diffuse Large B-Cell Lymphoma

Interventions: Drug: MT-3724
Drug: Gemcitabine
Drug: Oxaliplatin

First Posted Date: 2018-04-04

Last Posted Date: 2022-08-16

Lead Sponsor: Molecular Templates, Inc.

Target Recruit Count: 8

Registration Number: NCT03488251

Locations: 🇺🇸
UC Irvine Health / Chao Family Comprehensive Cancer Center, Orange, California, United States
🇺🇸
Innovative Clinical Research Institute, Whittier, California, United States
🇺🇸
Good Samaritan Hospital, Cincinnati, Ohio, United States

and more 6 locations