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

Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma

Phase 1

Completed

Conditions: Sarcoma

Interventions: Drug: Docetaxel
Drug: Gemcitabine
Drug: Vorinostat
Drug: Pegfilgrastim

First Posted Date: 2013-06-17

Last Posted Date: 2022-09-21

Lead Sponsor: Melissa Burgess, MD

Target Recruit Count: 37

Registration Number: NCT01879085

Locations: 🇺🇸
Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Phase 2

Active, not recruiting

Conditions: Medulloblastoma

Interventions: Radiation: Craniospinal Irradiation with boost to the primary tumor site
Drug: Cyclophosphamide
Drug: Cisplatin
Drug: Vincristine
Other: Aerobic Training
Drug: Vismodegib
Drug: Pemetrexed
Other: Neurocognitive Remediation
Drug: Gemcitabine

First Posted Date: 2013-06-17

Last Posted Date: 2024-11-26

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 660

Registration Number: NCT01878617

Locations: 🇺🇸
Rady Children's Hospital, San Diego, California, United States
🇺🇸
Texas Children's Cancer Center, Houston, Texas, United States
🇺🇸
Children's Hospital and Clinics of Minnesota, Minneapolis, Minnesota, United States

and more 20 locations

Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma

Phase 2

Conditions: Advanced Malignant Pleural Mesothelioma

Interventions: Drug: Gemcitabine
Drug: Cisplatin

First Posted Date: 2013-06-05

Last Posted Date: 2017-03-03

Lead Sponsor: Instituto Nacional de Cancerologia de Mexico

Target Recruit Count: 26

Registration Number: NCT01869023

Locations: 🇲🇽
Instituto Nacional de Cancerología, Mexico City, Mexico

Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)

Phase 2

Active, not recruiting

Conditions: Cholangiolar Carcinoma
Cholangiocellular Carcinoma
Peripheral Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma

Interventions: Drug: Floxuridine (FUDR)
Drug: dexamethasone
Drug: Gemcitabine
Drug: Oxaliplatin
Other: MRI
Other: Research blood draws

First Posted Date: 2013-05-24

Last Posted Date: 2024-07-01

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 55

Registration Number: NCT01862315

Locations: 🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Nassau, Uniondale, New York, United States

and more 2 locations