Gemzar® (gemcitabine HCl) is a nucleoside analogue that exhibits antitumor activity. Gemcitabine HCl is 2′-deoxy-2′,2′-difluorocytidine monohydrochloride (β–isomer).
Gemzar in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum–based therapy.
Gemzar 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.
Non–Small Cell Lung Cancer
Gemzar is indicated in combination with cisplatin for the first–line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non–small cell lung cancer.
Gemzar 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. Gemzar is indicated for patients previously treated with 5–FU.
Published Studies Related to Gemzar (Gemcitabine)
Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: a randomized controlled phase II trial. [2011.09.06]
BACKGROUND: Paclitaxel embedded in cationic liposomes (EndoTAG-1; ET) is an innovative agent targeting tumor endothelial cells. This randomized controlled phase II trial evaluated the safety and efficacy of ET in combination with gemcitabine (GEM) in advanced pancreatic cancer (PDAC)... CONCLUSIONS: Treatment of advanced PDAC with GEM + ET was generally well tolerated. GEM + ET showed beneficial survival and efficacy. A randomized phase III trial should confirm this positive trend.
Quality of life, geriatric assessment and survival in elderly patients with non-small-cell lung cancer treated with carboplatin-gemcitabine or carboplatin-paclitaxel: NVALT-3 a phase III study. [2011.07]
BACKGROUND: Elderly patients with advanced non-small-cell lung cancer (NSCLC) may derive similar benefit from platinum-based chemotherapy as younger patients. Quality of life (QoL) and comprehensive geriatric assessment (CGA) is often advocated to assess benefits and risks... CONCLUSIONS: Paclitaxel or gemcitabine added to carboplatin did not have a differential effect on global QoL. CGA was associated with toxic effects in a very limited manner. CGA and QoL items measure one underlying dimension, which is highly prognostic.
Sorafenib in combination with erlotinib or with gemcitabine in elderly patients with advanced non-small-cell lung cancer: a randomized phase II study. [2011.07]
BACKGROUND: Sorafenib is a small-molecule multitargeted kinase inhibitor that blocks the activation of C-RAF, B-RAF, c-KIT, FLT-3, RET, vascular endothelial growth factor receptor 2 (VEGFR-2), VEGFR-3 and platelet-derived growth factor receptor beta. The aim of this multicenter, randomized phase II study was to evaluate clinical activity and safety of sorafenib in combination with erlotinib or gemcitabine in unselected untreated elderly patients with non-small-cell lung cancer (NSCLC)... CONCLUSIONS: The combination of erlotinib and sorafenib was feasible in elderly patients with advanced NSCLC and was associated with a higher 1-year survival rate than the other arm. According to the selection design, this combination warrants further investigation in phase III trials.
Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study. [2011.06.20]
PURPOSE: To assess the activity and toxicity of the combination of gemcitabine plus dacarbazine (DTIC) in patients with advanced soft tissue sarcoma (STS) in a randomized, multicenter, phase II study using DTIC alone as a control arm... CONCLUSION: The combination of gemcitabine and DTIC is active and well tolerated in patients with STS, providing in this phase II randomized trial superior progression-free survival and overall survival than DTIC alone. This regimen constitutes a valuable therapeutic alternative for these patients.
An indirect comparison of bevacizumab plus cisplatin-gemcitabine and cisplatin plus pemetrexed treatment for patients with advanced first-line non-squamous non-small cell lung cancer in East Asia. [2011.06]
AIMS: To compare the relative efficacy of bevacizumab plus cisplatin-gemcitabine chemotherapy (BevCG) with cisplatin plus pemetrexed (CP) in the first-line treatment of advanced or recurrent non-small cell lung cancer (NSCLC) in East Asian patients. In the absence of evidence from head-to-head trials, an adjusted indirect treatment comparison (ITC) approach was selected to compare these treatments... CONCLUSION: BevCG can be considered a more effective therapy than CP for NSCLC patients in East Asia. (c) 2011 Blackwell Publishing Asia Pty Ltd.
Clinical Trials Related to Gemzar (Gemcitabine)
Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC [Active, not recruiting]
To assess the efficacy and safety of PF-3512676 administered in combination with
gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced
or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety
of gemcitabine/cisplatin alone.
Study of Treatment With Gemcitabine v. Tarceva v. Gemcitabine & Tarceva in Elderly Patients With NSCLC [Recruiting]
Patients to be enrolled on this study are 70 years old or older and have advanced or metastatic non-small cell lung cancer. Chemotherapy may be used to relieve symptoms but is not curative.
Patients who are 70 years old or older make up 30% of all lung cancer patients. Treatments for this subgroup of patients have not been well defined and results may differ from younger patient populations. For that reason, this study is being limited to the 70 years old or older age group.
The treatment received in this study consists of two drugs, gemcitabine and erlotinib. Gemcitabine is an active agent in the treatment of NCSLC and has shown to improve survival as a single agent. Gemcitabine is approved by the FDA for use in metastatic non-small cell lung cancer. Erlotinib is a drug that has shown promising activity against a number of types of cancer. Erlotinib is a new treatment that has been shown to slow or stop growth in tumors, including non-small cell lung cancer. Because erlotinib works differently from the way other chemotherapy drugs work, researchers believe that combining the gemcitabine and erlotinib may have added benefit. Recent studies have shown that erlotinib may work better in some people with a certain mutation in their tumor cells. For that reason, we would like to request some tumor samples to see if this mutation is present. This part of the study is optional. The purpose of the study is to observe the response to treatment in elderly patients with stage IIIB/IV non-small cell lung cancer treated with the combination of weekly gemcitabine and erlotinib.
A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer [Completed]
To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin
versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.
Comparison of Gemcitabine v. Gemcitabine Plus Docetaxel in Unresectable Soft Tissue Sarcoma [Completed]
The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and
docetaxel, to find out which treatment is better for people with sarcomas.
Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer [Active, not recruiting]
Development of an active second-line treatment option for metastatic breast cancer patients
previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative
For each randomisation arm, 47 patients will be included. The trial was performed as a
2-stage phase II study according to the optimal design by Simon with overall response rate as
the primary objective.
Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks
Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks
Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks
Reports of Suspected Gemzar (Gemcitabine) Side Effects
Neoplasm Progression (100),
Interstitial Lung Disease (57),
Renal Failure Acute (28),
White Blood Cell Count Decreased (28),
OFF Label USE (26),
Decreased Appetite (24), more >>