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Gemzar (Gemcitabine Hydrochloride) - Summary

 
 



GEMZAR SUMMARY

GEMZAR®
(GEMCITABINE HCl)
FOR INJECTION

Gemzar® (gemcitabine HCl) is a nucleoside analogue that exhibits antitumor activity. Gemcitabine HCl is 2′-deoxy-2′,2′-difluorocytidine monohydrochloride (β–isomer).

Therapeutic Indications

Ovarian Cancer

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.

Breast Cancer

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.

Pancreatic 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.


See all Gemzar indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Gemzar (Gemcitabine)

Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients. [2014]
placebo (GP) in patients with locally advanced and metastatic pancreatic cancer... CONCLUSIONS: Adding low-dose simvastatin to gemcitabine in advanced pancreatic

Sorafenib or placebo with either gemcitabine or capecitabine in patients with HER-2-negative advanced breast cancer that progressed during or after bevacizumab. [2013]
CONCLUSION: The addition of sorafenib to gemcitabine/capecitabine provided a

Pharmacodynamic stimulation of thrombogenesis by angiotensin (1-7) in recurrent ovarian cancer patients receiving gemcitabine and platinum-based chemotherapy. [2013]
scheduled dose intensity were also determined... CONCLUSIONS: A 100 mcg/kg dose of A(1-7) was shown to produce pharmacodynamic

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.

more studies >>

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 settings.

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.

Study Design:

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

more trials >>

Reports of Suspected Gemzar (Gemcitabine) Side Effects

Death (136)Neoplasm Progression (100)Interstitial Lung Disease (57)Thrombocytopenia (32)Anaemia (31)Renal Failure Acute (28)White Blood Cell Count Decreased (28)OFF Label USE (26)Pyrexia (25)Decreased Appetite (24)more >>


Page last updated: 2014-11-30

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