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
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A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast 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
30
Registration Number
NCT00191347
Locations
🇨🇦

For additional information regarding investigative sites for thsi 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., Ottawa, Ontario, Canada

Gemcitabine in Combination With Cisplatin as Neoadjuvant NSCLC Chemotherapy

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2006-07-24
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
50
Registration Number
NCT00191841
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, Ufa, Russian Federation

Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-09-19
Last Posted Date
2012-11-13
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
69
Registration Number
NCT00193453
Locations
🇺🇸

Gainsville Hematology Oncology Associates, Gainesville, Florida, United States

🇺🇸

Florida Cancer Specialists, Fort Myers, Florida, United States

🇺🇸

Northeast Arkansas Clinic, Jonesboro, Arkansas, United States

and more 7 locations

Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer

Phase 3
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2010-07-28
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
200
Registration Number
NCT00193362

Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2010-06-28
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
346
Registration Number
NCT00193323
Locations
🇺🇸

Tennessee Oncology, PLLC, Nashville, Tennessee, United States

Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-09-19
Last Posted Date
2022-03-03
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
72
Registration Number
NCT00193414
Locations
🇺🇸

Tennessee Oncology, Nashville, Tennessee, United States

Chemoradiotherapy in Patients With Localised Lung Cancer

First Posted Date
2005-09-19
Last Posted Date
2014-08-04
Lead Sponsor
Trans Tasman Radiation Oncology Group
Target Recruit Count
82
Registration Number
NCT00193921
Locations
🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

🇦🇺

Mater Misericordiae Hospital, Brisbane, Queensland, Australia

🇦🇺

Calvary Mater Newcastle, Newcastle, New South Wales, Australia

and more 5 locations

Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

First Posted Date
2005-09-19
Last Posted Date
2019-09-12
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
263
Registration Number
NCT00191126
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., Taichung, Taiwan

Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2011-05-03
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
96
Registration Number
NCT00193076
Locations
🇺🇸

Tennessee Oncology, Nashville, Tennessee, United States

An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy

First Posted Date
2005-09-19
Last Posted Date
2011-03-04
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
919
Registration Number
NCT00191646
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., San Juan, Puerto Rico

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