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

Gemcitabine in Ovarian Cancer

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: gemcitabine
Drug: cisplatin

First Posted Date: 2005-09-19

Last Posted Date: 2009-03-27

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 50

Registration Number: NCT00191334

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., Stavropol, Russian Federation

Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

Phase 3

Completed

Conditions: Breast Neoplasms

First Posted Date: 2005-09-19

Last Posted Date: 2007-05-28

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 300

Registration Number: NCT00191438

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., Nottingham City, Nottinghamshire, United Kingdom

A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer

Phase 2

Completed

Conditions: Superficial Bladder Cancer

First Posted Date: 2005-09-19

Last Posted Date: 2007-05-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 90

Registration Number: NCT00192049

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, Tel hashomer, Israel

Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.

Phase 2

Completed

Conditions: Non-Small-Cell Lung Carcinoma

First Posted Date: 2005-09-19

Last Posted Date: 2007-01-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 64

Registration Number: NCT00191620

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, Mexico City, Mexico

A Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Neoplasms

First Posted Date: 2005-09-19

Last Posted Date: 2007-01-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 120

Registration Number: NCT00191672

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 - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Katy, Texas, United States
🇺🇸
For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (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., Nashville, Tennessee, United States

A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

First Posted Date: 2005-09-19

Last Posted Date: 2007-01-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 162

Registration Number: NCT00191490

Locations: 🇮🇹
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 am to 5:00 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician, Sesto Fiorentino, Florence, Italy

Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

Phase 2

Completed

Conditions: Adenocarcinoma

First Posted Date: 2005-09-19

Last Posted Date: 2007-01-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 30

Registration Number: NCT00191503

Locations: 🇨🇦
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Edmonton, Alberta, Canada

Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer

Phase 2

Completed

Conditions: Carcinoma, Non Small Cell Lung

First Posted Date: 2005-09-19

Last Posted Date: 2007-01-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 77

Registration Number: NCT00191256

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

Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.

Phase 2

Completed

Conditions: Superficial Bladder Cancer

First Posted Date: 2005-09-19

Last Posted Date: 2007-01-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 43

Registration Number: NCT00191711

Locations: 🇮🇹
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician, Sesto Fiorentino, Florence, Italy

A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.

Phase 3

Completed

Conditions: Genital Neoplasms, Female
Fallopian Tube Neoplasms
Ovarian Neoplasms
Pelvic Neoplasms
Peritoneal Neoplasms

First Posted Date: 2005-09-19

Last Posted Date: 2007-01-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 162

Registration Number: NCT00191607

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 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., St. Louis, Missouri, United States

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