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
-

Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma

Phase 1
Terminated
Conditions
Pancreatic Ductal Adenocarcinoma
Interventions
Drug: LDE225-600mg
Drug: Gemcitabine
Drug: nab-paclitaxel
Drug: LDE225-400mg
Drug: LDE225-800mg
First Posted Date
2011-09-12
Last Posted Date
2020-01-22
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
23
Registration Number
NCT01431794
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Combination Study of GSK1120212 With Gemcitabine in Subjects With Solid Tumors

Phase 1
Completed
Conditions
Leukaemia, Myelocytic, Acute
Interventions
First Posted Date
2011-09-05
Last Posted Date
2017-11-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
31
Registration Number
NCT01428427
Locations
🇺🇸

GSK Investigational Site, San Antonio, Texas, United States

Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies

First Posted Date
2011-08-22
Last Posted Date
2015-11-18
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
78
Registration Number
NCT01421173
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer

Not Applicable
Conditions
Pancreas Cancer
Interventions
First Posted Date
2011-08-08
Last Posted Date
2014-10-03
Lead Sponsor
AHS Cancer Control Alberta
Target Recruit Count
20
Registration Number
NCT01411072
Locations
🇨🇦

Tom Baker Cancer Center, Calgary, Alberta, Canada

🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer

Phase 3
Active, not recruiting
Conditions
Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Metastatic
Interventions
First Posted Date
2011-07-29
Last Posted Date
2023-03-24
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
299
Registration Number
NCT01405586
Locations
🇮🇹

ASL Viterbo - Ospedale Belcolle, Viterbo, Italy

🇮🇹

Ospedale Villa Scassi, Genova, GE, Italy

🇮🇹

Azienda Ospedaliera Universitaria Senese, Siena, SI, Italy

and more 46 locations

Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer

First Posted Date
2011-07-06
Last Posted Date
2013-08-20
Lead Sponsor
WiSP Wissenschaftlicher Service Pharma GmbH
Target Recruit Count
140
Registration Number
NCT01388621
Locations
🇩🇪

Stauferklinikum Schwäbisch Gmünd, Mutlangen, Baden Württemberg, Germany

🇩🇪

Praxis Dr. Oettle, Friedrichshafen, Baden-Württemberg, Germany

🇩🇪

Carl-Thiem-Klinikum Cottbus Frauenklinik, Cottbus, Brandenburg, Germany

and more 15 locations

SOM 230 and Gemcitabine in Advanced Pancreatic Cancer

Phase 1
Completed
Conditions
Pancreatic Cancer
Interventions
Drug: SOM 230 LAR
Drug: Gemcitabine
First Posted Date
2011-06-30
Last Posted Date
2020-09-28
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
20
Registration Number
NCT01385956
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer

Phase 1
Completed
Conditions
Neoplasms
Neoplasm Metastasis
Pancreatic Cancer
Interventions
First Posted Date
2011-06-14
Last Posted Date
2018-05-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
170
Registration Number
NCT01373164
Locations
🇺🇸

Florida Hospital Tampa HPG and Foregut Surgery, Tampa, Florida, United States

🇺🇸

Ingalls Memorial Hospital, Harvey, Illinois, United States

🇪🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sevilla, Spain

and more 1 locations

New Treatment Option for Pancreatic Cancer

Phase 1
Completed
Conditions
Pancreatic Cancer
Interventions
Drug: Intravenous Vitamin C
Drug: Gemcitabine
First Posted Date
2011-06-02
Last Posted Date
2018-06-19
Lead Sponsor
Jeanne Drisko, MD, CNS, FACN
Target Recruit Count
14
Registration Number
NCT01364805
Locations
🇺🇸

University of Kansas Medical Center, Kansas City, Kansas, United States

Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer

Phase 3
Completed
Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
Drug: ON 01910.Na
Drug: Gemcitabine
First Posted Date
2011-05-26
Last Posted Date
2016-08-04
Lead Sponsor
Traws Pharma, Inc.
Target Recruit Count
160
Registration Number
NCT01360853
Locations
🇺🇸

Desert Comprehensive Cancer Center, Palm Springs, California, United States

🇺🇸

UCSD Moores Cancer Center, La Jolla, California, United States

🇺🇸

Premiere Oncology, Santa Monica, California, United States

and more 43 locations
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