ALIMTA SUMMARY
ALIMTA® , pemetrexed for injection, is an antifolate antineoplastic agent that exerts its action by disrupting folate-dependent metabolic processes essential for cell replication. Pemetrexed disodium heptahydrate has the chemical name L-Glutamic acid,
N
-[4-[2-(2-amino-4,7-dihydro-4-oxo-1
H
-pyrrolo[2,3-
d
]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate.
Mesothelioma: ALIMTA in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
Non-Small Cell Lung Cancer: ALIMTA as a single-agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.
The effectiveness of ALIMTA in second-line NSCLC was based on the surrogate endpoint, response rate. There are no controlled trials demonstrating a clinical benefit, such as a favorable survival effect or improvement of disease-related symptoms.
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NEWS HIGHLIGHTSMedia Articles Related to Alimta (Pemetrexed)
Alimta Approved as Maintenance Therapy for Advanced Lung Cancer
Source: MedicineNet Asbestos-Related Disorders Specialty [2009.07.07]
Title: Alimta Approved as Maintenance Therapy for Advanced Lung Cancer
Category: Health News
Created: 7/7/2009 7:00:00 AM
Last Editorial Review: 7/7/2009
Published Studies Related to Alimta (Pemetrexed)
Cost-Effectiveness of Pemetrexed Plus Cisplatin as First-Line Therapy for Advanced Nonsquamous Non-small Cell Lung Cancer. [2009.09.25]
INTRODUCTION:: To estimate the cost-effectiveness of first-line cisplatin/pemetrexed (Cis/Pem) compared with cisplatin/gemcitabine (Cis/Gem), carboplatin/paclitaxel (Carb/Pac), and carboplatin/paclitaxel/bevacizumab (Carb/Pac/Bev) in patients with advanced non-small cell lung cancer (NSCLC), particularly in those with nonsquamous cell histology (i.e., adenocarcinoma, large cell carcinoma, or histology not otherwise specified)... CONCLUSIONS:: Compared with commonly used and reimbursed regimens for first-line chemotherapy in advanced NSCLC, Cis/Pem may be considered cost-effective, particularly in patients with nonsquamous cell histology. This analysis emphasizes the importance of histology in identifying the appropriate patient for Cis/Pem first-line chemotherapy.
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.
Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. [2009.07.01]
PURPOSE To compare pemetrexed/carboplatin with a standard regimen as first-line therapy in advanced non-small-cell lung cancer NSCLC. PATIENTS AND METHODS Patients with stage IIIB or IV NSCLC and performance status of 0 to 2 were randomly assigned to receive pemetrexed 500 mg/m(2) plus carboplatin area under the curve (AUC) = 5 (Calvert's formula) on day 1 or gemcitabine 1,000 mg/m(2) on days 1 and 8 plus carboplatin AUC = 5 on day 1 every 3 weeks for up to four cycles...
PROCLAIM: A phase III study of pemetrexed, cisplatin, and radiation therapy followed by consolidation pemetrexed versus etoposide, cisplatin, and radiation therapy followed by consolidation cytotoxic chemotherapy of choice in locally advanced stage III non-small-cell lung cancer of other than predominantly squamous cell histology. [2009.05]
This clinical trial summary provides the background and rationale for a randomized trial examining the benefits of pemetrexed/ cisplatin chemotherapy combined with radiation followed by consolidation pemetrexed in patients with unresectable stage IIIA/B non-small-cell lung cancer.
A randomised, double-blind, phase II study of two doses of pemetrexed in the treatment of platinum-resistant, epithelial ovarian or primary peritoneal cancer. [2009.05]
PURPOSE: We conducted a randomised phase II study to assess the safety and efficacy of standard versus high-dose pemetrexed in platinum-resistant epithelial ovarian cancer (PR-EOC). The expression of ten genes was also examined as potential biomarkers of pemetrexed/platinum activity... CONCLUSIONS: Pemetrexed has activity in PR-EOC equivalent to other agents in platinum-resistant disease; however, Pem500 has the preferable toxicity profile. ERCC1 and RFC1 may merit examination as predictive biomarkers in PR-EOC.
Clinical Trials Related to Alimta (Pemetrexed)
Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients [Active, not recruiting]
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop
them from dividing, or stop the growth of the blood supply that cancers need to grow and
spread. Clinical research has shown that drugs that inhibit vascular endothelial growth
factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase
overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical
studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR
signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking
their blood supply and by stopping them from dividing. This lung cancer study is to
investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta
(pemetrexed) alone.
Study of AlimtaŽ (Pemetrexed) Plus VELCADEŽ (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Therapy [Completed]
The purpose of this study is to establish the objective response rate (complete response +
partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE
alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who
have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment
group will be used as the control. The VELCADE single-agent treatment group will be used to
determine if VELCADE administered weekly can demonstrate response rates.
ZD6474(Vandetanib) + Alimta Combo Study [Active, not recruiting]
The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets)
to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help
control their symptoms and disease better than the chemotherapy alone.
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas. [Completed]
Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA
for the treatment of cancer of the pancreas. Patients may be able to participate in this
study if they have cancer in their pancreas that cannot be removed by surgery OR that has
spread to a new site in their body.
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer [Completed]
To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed
for the treatment of patients with locally advanced or metastatic NSCLC who have failed one
prior chemotherapy regimen
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