MedPath

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
-

Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

Phase 3
Active, not recruiting
Conditions
Childhood Malignant Liver Neoplasm
Hepatoblastoma
Fibrolamellar Carcinoma
Childhood Hepatocellular Carcinoma
Hepatocellular Malignant Neoplasm, Not Otherwise Specified
Interventions
First Posted Date
2018-05-23
Last Posted Date
2024-12-05
Lead Sponsor
Children's Oncology Group
Target Recruit Count
537
Registration Number
NCT03533582
Locations
🇺🇸

Henry Ford Health Saint John Hospital, Detroit, Michigan, United States

🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

Providence Alaska Medical Center, Anchorage, Alaska, United States

and more 202 locations

Scheduling Nab-paclitaxel With Gemcitabine

Phase 2
Completed
Conditions
Pancreatic Adenocarcinoma Metastatic
Interventions
First Posted Date
2018-05-18
Last Posted Date
2019-07-16
Lead Sponsor
CCTU- Cancer Theme
Target Recruit Count
146
Registration Number
NCT03529175
Locations
🇬🇧

Colchester Hospital, Colchester, United Kingdom

🇬🇧

The Royal Surrey County Hospital, Guildford, United Kingdom

🇬🇧

St James' Institute of Oncology, Leeds, United Kingdom

and more 20 locations

NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma

Phase 1
Terminated
Conditions
Soft Tissue Sarcoma
Interventions
First Posted Date
2018-05-15
Last Posted Date
2022-09-28
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
39
Registration Number
NCT03524898
Locations
🇨🇭

Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland

🇨🇭

CHUV - Swiss Cancer Center Lausanne, Lausanne, Switzerland

🇨🇭

Kantonsspital St. Gallen, St. Gallen, Switzerland

and more 5 locations

Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Metastatic Pancreatic Cancer

Phase 1
Active, not recruiting
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2018-05-11
Last Posted Date
2024-07-31
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
36
Registration Number
NCT03520790
Locations
🇺🇸

Penn Medicine, Philadelphia, Pennsylvania, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases

Phase 2
Completed
Conditions
Urothelial Carcinoma
Kidney Cancer
Bladder Cancer
Ureter Cancer
Interventions
Other: Denosumab Placebo
Drug: Denosumab
Drug: Gemcitabine
Drug: Carboplatin
Drug: Cisplatin
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
First Posted Date
2018-05-09
Last Posted Date
2021-11-23
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
6
Registration Number
NCT03520231
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

Early Phase 1
Terminated
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2018-05-08
Last Posted Date
2024-03-15
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Target Recruit Count
3
Registration Number
NCT03519308
Locations
🇺🇸

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Phase 1
Completed
Conditions
Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
Interventions
First Posted Date
2018-05-07
Last Posted Date
2024-08-28
Lead Sponsor
Lisata Therapeutics, Inc.
Target Recruit Count
30
Registration Number
NCT03517176
Locations
🇦🇺

Alfred Hospital, Melbourne, Victoria, Australia

🇦🇺

Queen Elizabeth Hospital, Woodville South, South Australia, Australia

🇦🇺

St John of God Hospital, Subiaco, Western Australia, Australia

Nab-paclitaxel in Combination with Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors

Phase 1
Completed
Conditions
Cancer
Interventions
First Posted Date
2018-04-25
Last Posted Date
2024-10-04
Lead Sponsor
Emory University
Target Recruit Count
24
Registration Number
NCT03507491
Locations
🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

🇺🇸

Chilldren's Healthcare of Atlanta, Atlanta, Georgia, United States

🇺🇸

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States

and more 1 locations

A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors

First Posted Date
2018-04-20
Last Posted Date
2018-04-20
Lead Sponsor
SuZhou Stainwei Biotech Inc.
Target Recruit Count
18
Registration Number
NCT03503604
Locations
🇨🇳

Shanghai East Hospital, Shanghai, Shanghai, China

Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer

Phase 2
Recruiting
Conditions
Chemotherapy Effect
Pancreatic Cancer
Interventions
First Posted Date
2018-04-13
Last Posted Date
2018-05-30
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
480
Registration Number
NCT03498326
Locations
🇨🇳

the second affiliated hospital of Zhejiang University, Hangzhou, Zhejiang, China

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