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Vinorelbine (Vinorelbine Tartrate) - Summary

 



WARNING

Vinorelbine Tartrate Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous (IV) use only. Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled “WARNING - FOR IV USE ONLY. FATAL if given intrathecally.”

Severe granulocytopenia resulting in increased susceptibility to infection may occur. Granulocyte counts should be ≥1,000 cells/mm3 prior to the administration of Vinorelbine. The dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment.

Caution - It is extremely important that the intravenous needle or catheter be properly positioned before Vinorelbine is injected. Administration of Vinorelbine may result in extravasation causing local tissue necrosis and/or thrombophlebitis (see DOSAGE AND ADMINISTRATION: Administration Precautions).

 

VINORELBINE SUMMARY

Vinorelbine Tartrate Injection is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10 mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection, USP. No preservatives or other additives are present. The aqueous solution is sterile and nonpyrogenic. Vinorelbine tartrate is a semi-synthetic vinca alkaloid with antitumor activity.

Vinorelbine is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer (NSCLC). In patients with Stage IV NSCLC, Vinorelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, Vinorelbine is indicated in combination with cisplatin.


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NEWS HIGHLIGHTS

Media Articles Related to Vinorelbine

ASCO Releases Updated Treatment Guidelines For Patients With Stage 4 Non-Small Cell Lung Cancer
Source: Lung Cancer News From Medical News Today [2009.11.17]
New recommendations on the use of chemotherapy to treat patients with stage 4 non-small cell lung cancer (NSCLC) were issued today by the American Society of Clinical Oncology (ASCO). The evidence-based clinical practice guideline indicates a patient's physical age should not determine the cancer treatment he/she is given.

In Non-Small Cell Lung Cancer PET Imaging Before Radiation Not Ideal For Determining Boost Radiation Doses
Source: Lung Cancer News From Medical News Today [2009.11.04]
Positron emission tomography (PET) imaging of non-small cell lung cancer prior to receiving radiation therapy should not be the basis for determining areas that may benefit from higher doses of radiation, according to research presented by investigators at Thomas Jefferson University Hospital at the 51st ASTRO Annual Meeting (Abstract #2583/B-186).

What Are The Real Benefits Versus Risks Of Preventative Brain Radiation For Patients With Non-small Cell Lung Cancer?
Source: Lung Cancer News From Medical News Today [2009.11.03]
Patients with non-small cell lung cancer treated with preventative brain radiation (called prophylactic cranial irradiation or PCI), significantly decrease their risk of developing brain metastases (cancer spread in the brain) by more than 50 percent (from 18 percent to 8 percent), compared to th

PET Imaging Response A Prognostic Factor After Thoracic Radiation Therapy For Lung Cancer
Source: Lung Cancer News From Medical News Today [2009.11.07]
A rapid decline in metabolic activity on a PET scan after radiation therapy for non-small cell lung cancer is correlated with good local tumor control, according to a study presented by researchers at Thomas Jefferson University Hospital at the 51st ASTRO Annual Meeting. In addition, the researchers also found that the higher the metabolic activity and tumor size on a PET scan before treatment, the more likely a patient is to die from lung cancer.

New Treatment Option Emerging For Some With Early Stage Lung Cancer
Source: Lung Cancer News From Medical News Today [2009.11.04]
Patients with early stage, non-small cell lung cancer who are not able to undergo surgery, now have a highly effective treatment option. Physicians say that option, radical stereotactic radiosurgery performed with CyberKnife, leads to a 100 percent overall survival after three years in patients with good lung function before treatment. These are the results of a study presented at the annual CHEST meeting in San Diego.

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Published Studies Related to Vinorelbine

Global Lung Oncology Branch trial 3 (GLOB3): final results of a randomised multinational phase III study alternating oral and i.v. vinorelbine plus cisplatin versus docetaxel plus cisplatin as first-line treatment of advanced non-small-cell lung cancer. [2009.07]
BACKGROUND: The study compared the efficacy of a first-line treatment with day 1 i.v. vinorelbine (NVBiv) and day 8 oral vinorelbine (NVBo) versus docetaxel (DCT) in a cisplatin-based combination in advanced non-small-cell lung cancer, in terms of time to treatment failure (TTF), overall response, progression-free survival (PFS), overall survival (OS), tolerance and quality of life (QoL)... CONCLUSIONS: Both arms provided similar efficacy in terms of response, time-related parameters and QoL, with an acceptable tolerance profile. In the current Global Lung Oncology Branch trial 3, NVBo was shown to be effective as a substitute for the i.v. formulation. This can relieve the burden of the i.v. injection on day 8 and can optimise the hospital's resources and improve patient convenience.

Paclitaxel and carboplatin vs gemcitabine and vinorelbine in patients with adeno- or undifferentiated carcinoma of unknown primary: a randomised prospective phase II trial. [2009.01.13]
Platinum/taxane combinations are widely used in patients with carcinoma of unknown primary (CUP), yielding response rates of 30% and median overall survival of 9-11 months in selected patients... In conclusion, the paclitaxel/carboplatin regimen showed clinically meaningful activity in this randomised trial (Clinical trial registration number 219, 'Deutsches KrebsStudienRegister', German Cancer Society.).

Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-small-cell lung cancer: a randomised, open-label, phase III study. [2008.12]
BACKGROUND: Platinum-containing two-drug combinations improve survival and cancer-related symptoms in patients with advanced non-small-cell lung cancer (NSCLC). However, survival benefit is modest and platinum-containing regimens cause substantial toxic effects. We did a prospective randomised open-label phase III study to compare an experimental platinum-free, triplet, sequential regimen of vinorelbine plus gemcitabine followed by docetaxel with the standard platinum-containing, doublet regimen paclitaxel plus carboplatin in patients with advanced NSCLC... INTERPRETATION: Although platinum-containing regimens remain the standard treatment for advanced NSCLC, non-platinum regimens could provide equivalent efficacy with a different toxicity profile.

A randomized study of gemcitabine plus cisplatin and vinorelbine plus cisplatin in patients with advanced non-small-cell lung cancer. [2008.11]
BACKGROUND: Gemcitabine plus cisplatin (GC) and vinorelbine plus cisplatin (VC) are active and well-tolerated regimens for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). We conducted this study to compare the safety and efficacy of these regimens as front-line chemotherapy for patients with NSCLC... CONCLUSIONS: Both vinorelbine plus cisplatin and gemcitabine plus cisplatin yielded similar efficacies for NSCLC.

Randomized cross-over study of patient preference for oral or intravenous vinorelbine in combination with carboplatin in the treatment of advanced NSCLC. [2008.10]
BACKGROUND: Most chemotherapeutics are administrated intravenously (iv), but some are also available in an oral (po) formulation. This study was designed with the primary objective to estimate the patients' preference for po or iv vinorelbine in combination with carboplatin for the palliative treatment of non-small cell lung cancer (NSCLC). Secondary aims were to evaluate toxicity, efficacy, and subjective reasons the preference... CONCLUSION: Three out of four patients preferred oral vinorelbine. Clinical outcomes were comparable to other combination chemotherapy regimens for NSCLC.

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Clinical Trials Related to Vinorelbine

Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer [Completed]
The purpose of this study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.

Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer [Completed]
The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.

Metronomic Oral Vinorelbine in Patients With Metastatic Tumors [Completed]
Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic schedule three times a week: on Monday, Wednesday and Friday.

Study of Cisplatin/Vinorelbine +/- Cetuximab as First-Line Treatment of Advanced Non Small Cell Lung Cancer(FLEX) [Completed]
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma [Completed]
The purpose of this study is to collect anti-tumor activity of vinorelbine when given to patients with esophageal or gastric tumors. We will also collect information on the toxicities of vinorelbine in these patients.

more trials >>

Page last updated: 2009-11-17

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