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

Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer

Phase 2

Withdrawn

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: CPI-613
Drug: Any non-gemcitabine chemotherapies or best supportive care
Drug: Gemcitabine

First Posted Date: 2013-04-12

Last Posted Date: 2013-08-14

Lead Sponsor: Cornerstone Pharmaceuticals

Registration Number: NCT01830322

Locations: 🇺🇸
Temple Vasicek Cancer Treatment Center, Temple, Texas, United States
🇺🇸
Eastchester Center for Cancer Care, Bronx, New York, United States

Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma

Phase 2

Completed

Conditions: Recurrent Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder

Interventions: Biological: Trastuzumab
Drug: Gemcitabine
Drug: Carboplatin
Drug: Cisplatin

First Posted Date: 2013-04-11

Last Posted Date: 2017-02-06

Lead Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Target Recruit Count: 61

Registration Number: NCT01828736

Locations: 🇫🇷
Curie Institute, Paris, France
🇫🇷
Hôpital Européen Georges Pompidou, Paris, France
🇫🇷
Centre Hospitalier Départemental de la Vendée, La Roche-sur-yon, France

and more 12 locations

First Line Gemcitabine, Cisplatin and MEK162 in Advanced Biliary Tract Carcinoma

Phase 1

Completed

Conditions: Advanced Biliary Tract Carcinoma

Interventions: Drug: Gemcitabine
Drug: Cisplatin
Drug: MEK162

First Posted Date: 2013-04-10

Last Posted Date: 2020-11-17

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 42

Registration Number: NCT01828034

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumors
Pancreatic Cancer

Interventions: Drug: ruxolitinib
Drug: gemcitabine
Drug: nab-paclitaxel
Drug: filgrastim

First Posted Date: 2013-04-02

Last Posted Date: 2018-02-12

Lead Sponsor: Incyte Corporation

Target Recruit Count: 42

Registration Number: NCT01822756

Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients With Pancreatic Cancer

Early Phase 1

Completed

Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer

Interventions: Drug: oxaliplatin
Drug: irinotecan
Drug: leucovorin
Drug: 5-fluorouracil
Drug: capecitabine
Radiation: radiation
Procedure: surgery
Drug: gemcitabine

First Posted Date: 2013-04-01

Last Posted Date: 2018-09-04

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 23

Registration Number: NCT01821612

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

and more 11 locations