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
- -
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
- Conditions
- HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
- Interventions
- First Posted Date
- 2019-04-29
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 74
- Registration Number
- NCT03929666
- Locations
- 🇺🇸
Virginia Mason Medical Center, Seattle, Washington, United States
🇺🇸H. Lee Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- First Posted Date
- 2019-04-26
- Last Posted Date
- 2019-04-26
- Lead Sponsor
- Fudan University
- Target Recruit Count
- 120
- Registration Number
- NCT03929094
- Locations
- 🇨🇳
FUDAN University, Shanghai, Shanghai, China
Breast Cancer Treatment Based on Organ-like Culture
- Conditions
- Breast Cancer Organoids
- Interventions
- Drug: TrastuzumabDrug: Doxorubicin HydrochlorideDrug: Epirubicin hydrochlorideDrug: FluorouracilDrug: PaclitaxelDrug: GemcitabineDrug: CisplatinDrug: Recombinant Human EndostatinDrug: Pirarubicin hydrochlorideDrug: PyrrolidineDrug: IxabepiloneDrug: Tamoxifen citrateDrug: Vinorelbine tartrateDrug: CarboplatinDrug: MethotrexateDrug: Eribulin mesylateDrug: Toremifene citrateDrug: AnastrozoleDrug: LetrozoleDrug: ExemestaneDrug: FulvestrantDrug: OlaparibDrug: BevacizumabDrug: Apatinib mesylateDrug: PattozumabDrug: CapecitabineDrug: Ear particlesDrug: Aidi InjectionDrug: Cyclophosphamide
- First Posted Date
- 2019-04-24
- Last Posted Date
- 2019-04-24
- Lead Sponsor
- Xijing Hospital
- Target Recruit Count
- 300
- Registration Number
- NCT03925233
- Locations
- 🇨🇳
JingSu, Xi'an, Shaanxi, China
Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
- Conditions
- Bladder Cancer
- Interventions
- Drug: PembrolizumabDrug: GemcitabineDrug: CisplatinProcedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])Drug: Placebo
- First Posted Date
- 2019-04-23
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 907
- Registration Number
- NCT03924856
- Locations
- 🇨🇦
Princess Margaret Cancer Centre ( Site 0107), Toronto, Ontario, Canada
🇺🇸Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033), Seattle, Washington, United States
🇺🇸Scripps MD Anderson ( Site 0010), La Jolla, California, United States
Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer
- Conditions
- Recurrent or Metastatic Nasopharyngeal Cancer
- Interventions
- First Posted Date
- 2019-04-23
- Last Posted Date
- 2024-07-16
- Lead Sponsor
- BeiGene
- Target Recruit Count
- 263
- Registration Number
- NCT03924986
- Locations
- 🇨🇳
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
🇨🇳Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, China
🇨🇳Anhui Provincial Cancer Hospital, Hefei, Anhui, China
INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
- Conditions
- Advanced and/or Metastatic Solid TumorsStage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung CancerAdvanced/Metastatic Unresectable Malignant Pleural Mesothelioma
- Interventions
- First Posted Date
- 2019-04-19
- Last Posted Date
- 2020-04-24
- Lead Sponsor
- Incyte Corporation
- Registration Number
- NCT03920839
A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)
- Conditions
- Neoplasms
- Interventions
- First Posted Date
- 2019-04-17
- Last Posted Date
- 2024-12-12
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 230
- Registration Number
- NCT03918278
- Locations
- 🇺🇸
Next Oncology ( Site 0001), San Antonio, Texas, United States
🇨🇦Princess Margaret Cancer Centre ( Site 0011), Toronto, Ontario, Canada
🇨🇦BC Cancer - Vancouver Center ( Site 0010), Vancouver, British Columbia, Canada
Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer
- Conditions
- Bladder AdenocarcinomaBladder Mixed AdenocarcinomaBladder Squamous Cell CarcinomaBladder Urothelial CarcinomaInfiltrating Bladder Urothelial Carcinoma Sarcomatoid VariantInfiltrating Bladder Urothelial Carcinoma With Giant CellsInfiltrating Bladder Urothelial Carcinoma With Glandular DifferentiationInfiltrating Bladder Urothelial Carcinoma With Trophoblastic DifferentiationInfiltrating Bladder Urothelial Carcinoma, Clear Cell VariantInfiltrating Bladder Urothelial Carcinoma, Micropapillary Variant
- Interventions
- Drug: CisplatinDrug: CarboplatinProcedure: CystectomyBiological: DurvalumabDrug: DoxorubicinDrug: GemcitabineDrug: MethotrexateDrug: Vinblastine
- First Posted Date
- 2019-04-11
- Last Posted Date
- 2023-09-11
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 7
- Registration Number
- NCT03912818
- Locations
- 🇺🇸
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer
- Conditions
- Locally Advanced Unresectable Pancreatic AdenocarcinomaRecurrent Pancreatic AdenocarcinomaMetastatic Pancreatic AdenocarcinomaStage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8
- Interventions
- First Posted Date
- 2019-04-10
- Last Posted Date
- 2023-08-29
- Lead Sponsor
- Emory University
- Target Recruit Count
- 22
- Registration Number
- NCT03910387
- Locations
- 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
High Dose Ascorbic Acid and Nanoparticle Paclitaxel Protein Bound and Cisplatin and Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer
- Conditions
- Metastatic Pancreatic CancerPancreatic CancerPancreas CancerPancreatic Adenocarcinoma ResectablePancreatic MetastasisPancreatic Ductal Adenocarcinoma
- Interventions
- First Posted Date
- 2019-04-09
- Last Posted Date
- 2019-05-30
- Lead Sponsor
- Medical College of Wisconsin
- Registration Number
- NCT03908333
- Locations
- 🇺🇸
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
🇺🇸HonorHealth Research Institute, Scottsdale, Arizona, United States
🇺🇸University of California San Diego Moores Cancer Center, San Diego, California, United States
Drug Development Updates
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