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.
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NEWS HIGHLIGHTSMedia Articles Related to Gemzar (Gemcitabine)
Trial To Test Experimental Drug For Advanced Pancreatic Cancer
Source: Health News from Medical News Today [2010.09.02]
Cancer Research UK's Drug Development Office has launched a clinical trial* to test an experimental drug in patients with advanced (Stage IV) pancreatic cancer - one of the most difficult cancers to treat. Around 60 patients with advanced pancreatic cancer will be recruited for the first Phase I/IIclinical trial of a drug called MK-0752** in this disease. MK-0752 will be administered in combination with the standard treatment for advanced pancreatic cancer, gemcitabine*** . Trials have already tested the effects of the drug when administered in isolation...
Published Studies Related to Gemzar (Gemcitabine)
Randomized Double-Blind Placebo-Controlled Trial of Thalidomide in Combination With Gemcitabine and Carboplatin in Advanced Non-Small-Cell Lung Cancer. [2009.10.13]
PURPOSE: Cancers rely on angiogenesis for their growth and dissemination. We hypothesized that thalidomide, an oral antiangiogenic agent, when combined with chemotherapy, and as maintenance treatment, would improve survival in patients with advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: In this large trial of patients with NSCLC, thalidomide in combination with chemotherapy did not improve survival overall, but increased the risk of thrombotic events. Unexpectedly, survival was significantly worse in patients with nonsquamous histology.
CA 19-9 as a biomarker in advanced pancreatic cancer patients randomised to gemcitabine plus axitinib or gemcitabine alone. [2009.10.06]
BACKGROUND: Response assessment in advanced pancreatic cancer (APC) is difficult and predictive markers are needed. There are insufficient data on the value of carbohydrate antigen 19-9 (CA 19-9) and cytostatic-targeted therapies. Axitinib, a selective vascular endothelial growth factor (VEGF) receptors 1, 2, 3 inhibitor, may increase overall survival (OS) in APC... CONCLUSION: Baseline CA 19-9 levels had prognostic value for OS, but caution is advised in interpreting CA 19-9 as a predictive biomarker for novel cytostatic agents such as VEGF-targeted therapies in phase II studies.
A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. [2009.09.15]
BACKGROUND: This multicentre randomised phase III trial was designed to determine whether adjuvant chemotherapy with gemcitabine improves the outcomes of patients with resected pancreatic cancer... CONCLUSION: The current results suggest that adjuvant gemcitabine contributes to prolonged DFS in patients undergoing macroscopically curative resection of pancreatic cancer.
Survival without toxicity for cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemonaive patients with advanced non-small cell lung cancer: a risk-benefit analysis of a large phase III study. [2009.09]
BACKGROUND: In a large phase III study, cisplatin and pemetrexed had non-inferior efficacy and better tolerability compared with cisplatin and gemcitabine in chemonaive patients with non-small cell lung cancer (NSCLC). The current analysis characterised the clinical benefit (i.e. survival) relative to clinical risk (i.e. drug-related toxicity) of the doublets... CONCLUSIONS: Patients with non-squamous NSCLC treated with front-line cisplatin and pemetrexed have superior survival without toxicity (i.e. clinical benefit-to-risk profile) compared with patients treated with cisplatin and gemcitabine.
Gemcitabine alone or in combination with cisplatin in patients with advanced or metastatic cholangiocarcinomas or other biliary tract tumours: a multicentre randomised phase II study - The UK ABC-01 Study. [2009.08.18]
BACKGROUND: We assessed the activity of gemcitabine (G) and cisplatin/gemcitabine (C/G) in patients with locally advanced (LA) or metastatic (M) (advanced) biliary cancers (ABC) for whom there is no standard chemotherapy... CONCLUSION: Both regimens seem active in ABC. C/G is associated with an improved tumour control rate, TTP and 6-month PFS. The study has been extended (ABC-02 study) and powered to determine the effect on overall survival and the quality of life.
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
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