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

Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer

Phase 2

Terminated

Conditions: Metastatic Pancreatic Cancer

Interventions: Drug: ACP-196
Drug: Nab-paclitaxel
Drug: Gemcitabine

First Posted Date: 2015-10-07

Last Posted Date: 2019-08-28

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 3

Registration Number: NCT02570711

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Florida Cancer Specialists, Fort Myers, Florida, United States
🇺🇸
Ventura Clinical Trials, Ventura, California, United States

and more 6 locations

Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer

Phase 2

Active, not recruiting

Conditions: Stage IV Bladder Urothelial Carcinoma AJCC v7
Metastatic Renal Pelvis and Ureter Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma

Interventions: Drug: Berzosertib
Drug: Cisplatin
Drug: Gemcitabine Hydrochloride

First Posted Date: 2015-10-05

Last Posted Date: 2024-10-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 87

Registration Number: NCT02567409

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

and more 36 locations

A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Capecitabine
Drug: Gemcitabine

First Posted Date: 2015-10-01

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 63

Registration Number: NCT02565641

Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

Phase 1

Completed

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: Ibrutinib
Drug: Paclitaxel
Drug: Gemcitabine

First Posted Date: 2015-09-29

Last Posted Date: 2021-05-06

Lead Sponsor: Margaret Tempero

Target Recruit Count: 18

Registration Number: NCT02562898

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Oregon Health and Science University, Portland, Oregon, United States