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
-

Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma

Phase 2
Completed
Conditions
First Posted Date
2005-09-21
Last Posted Date
2015-03-31
Lead Sponsor
Institut Claudius Regaud
Target Recruit Count
50
Registration Number
NCT00210041
Locations
🇫🇷

Centre Paul Papin, Angers, France

🇫🇷

Centre François Baclesse, Caen, France

🇫🇷

Institut Bergonie, Bordeaux, France

and more 8 locations

Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

Phase 1
Suspended
Conditions
First Posted Date
2005-09-21
Last Posted Date
2007-11-01
Lead Sponsor
Hokkaido Gastrointestinal Cancer Study Group
Target Recruit Count
40
Registration Number
NCT00209677
Locations
🇯🇵

Hokkaido University Hospital (Hokkaido University Graduate School of Medicine), Sapporo, Hokkaido, Japan

Gemcitabine/ Trastuzumab and Gemcitabine/ Cisplatin/ Trastuzumab in Patients With Metastatic Breast Cancer

First Posted Date
2005-09-20
Last Posted Date
2017-12-27
Lead Sponsor
Kari Kendra
Target Recruit Count
10
Registration Number
NCT00201760
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

Etanercept and Gemcitabine in Patients With Advanced, Chemotherapy Naive Pancreatic Adenocarcinoma

First Posted Date
2005-09-20
Last Posted Date
2017-11-30
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Target Recruit Count
38
Registration Number
NCT00201838
Locations
🇺🇸

Ohio State University Medical Center, Columbus, Ohio, United States

Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

First Posted Date
2005-09-20
Last Posted Date
2010-04-30
Lead Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Target Recruit Count
126
Registration Number
NCT00198393
Locations
🇫🇷

CHU Grenoble - pneumologie, Grenoble, France

🇫🇷

CHU Avicenne - Oncologie, Bobigny, France

Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-09-20
Last Posted Date
2007-11-12
Lead Sponsor
University Hospital, Limoges
Target Recruit Count
227
Registration Number
NCT00199758
Locations
🇫🇷

Hôpital Charles Nicolle, Service de Pneumologie, Rouen, France

🇫🇷

Service de Pathologie Respiratoire, Toulon naval, France

🇫🇷

Service de Pneumologie, Villefranche, France

and more 7 locations

Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

First Posted Date
2005-09-19
Last Posted Date
2010-07-27
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
65
Registration Number
NCT00191789
Locations
🇮🇳

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

Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

First Posted Date
2005-09-19
Last Posted Date
2013-05-03
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
198
Registration Number
NCT00193596
Locations
🇺🇸

Tower Oncology, Beverly Hills, California, United States

🇺🇸

Clearview Cancer Institute, Huntsville, Alabama, United States

🇺🇸

Jackson Oncology Associates, Jackson, Mississippi, United States

and more 28 locations

Gemcitabine/Platinum Containing Regimens as Preoperative Chemotherapy for Patients With Non Small Cell Lung Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2007-01-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
70
Registration Number
NCT00191230
Locations
🇺🇸

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

Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

First Posted Date
2005-09-19
Last Posted Date
2009-08-11
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
515
Registration Number
NCT00191100
Locations
🇹🇭

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., Bangkok, Thailand

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