Alimta (Pemetrexed Disodium) - Summary

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.

Nonsquamous Non-Small Cell Lung Cancer – Combination with Cisplatin

ALIMTA^® is indicated in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer.

Nonsquamous Non-Small Cell Lung Cancer – Maintenance

ALIMTA is indicated for the maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

Nonsquamous Non-Small Cell Lung Cancer – After Prior Chemotherapy

ALIMTA is indicated as a single-agent for the treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy.

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.

Limitations of Use

ALIMTA is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. [see Clinical Studies (14.1, 14.2, 14.3)]

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NEWS HIGHLIGHTS

Published Studies Related to Alimta (Pemetrexed)

Pemetrexed in combination with cisplatin versus cisplatin monotherapy in East Asian patients with recurrent or metastatic head and neck cancer: Results of an exploratory subgroup analysis of a phase III trial. [2013]
trial was conducted to assess efficacy and safety trends based on ethnicity... CONCLUSION: Consistent with findings in the global population,

Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. [2012]
pemetrexed-cisplatin for SCCHN... CONCLUSIONS: Pemetrexed-cisplatin compared with placebo-cisplatin did not

Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. [2012]
palliation, and tolerability are presented here... INTERPRETATION: Quality of life during maintenance therapy with pemetrexed is

A phase II randomized study of cisplatin-pemetrexed plus either enzastaurin or placebo in chemonaive patients with advanced non-small cell lung cancer. [2012]
non-small cell lung cancer (NSCLC)... CONCLUSIONS: Enzastaurin and cisplatin-pemetrexed is tolerable with preliminary

Efficacy and safety of pemetrexed maintenance therapy versus best supportive care in patients from East Asia with advanced, nonsquamous non-small cell lung cancer: an exploratory subgroup analysis of a global, randomized, phase 3 clinical trial. [2012]
non-East Asian patients treated with pemetrexed or placebo... CONCLUSION: The results of this subgroup analysis support pemetrexed as

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Clinical Trials Related to Alimta (Pemetrexed)

Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer [Active, not recruiting]
The goal of this clinical research study is to learn how effective the drug pemetrexed (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (inability to perform every day activities without difficulty). Objectives: Primary Objectives:

- PS = 2 cohort: Response

- PS = 3 cohort: Descriptive

Secondary Objectives:

- Tolerability of single agent pemetrexed (Alimta®) in PS = 3 NSCLC patients

- Improved symptoms (both cohorts)

- Molecular Correlative studies (both cohorts)

- Overall survival

- Time to progression

Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer [Completed]
Primary Objective:

- To determine the maximum tolerated doses (MTDs) of pemetrexed when given with

dexamethasone. (Please note: One of the three treatment groups will not receive dexamethasone) Secondary Objectives:

- To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia > 7

days duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4 non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase toxicity.

- To determine objective response rate, as defined as complete response (CR) or partial

response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.

Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) [Completed]
The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial. The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.

Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma [Completed]
Primary Objective:

- To determine the maximum tolerated dose of the combination of cisplatin, imatinib

mesylate, and pemetrexed in metastatic malignant mesothelioma. Secondary Objectives:

- To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on

tumor tissue by:

- histologic analysis of biopsy tissue

- by non-invasive assessments of tumor vascularity performed before, during and after

treatment

- electron microscopy analysis of endothelial cell architecture after patient treatment

with imatinib mesylate

- To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate

markers in serum.

- To assess the rate of response to therapy.

- To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and

pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor (PDGF-R) on malignant mesothelioma tumor cells.

- To determine the pharmacokinetic interaction between agents in this combination

regimen.

Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed) or of the combination of 3 study drugs that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied. Crizotinib is designed to block a protein called ALK, which is involved in cancer cell growth and survival. Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells. Pemetrexed is designed to block proteins that may cause tumors to grow.

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Reports of Suspected Alimta (Pemetrexed) Side Effects

Death (116),  Neoplasm Progression (81),  Thrombocytopenia (53),  Dyspnoea (49),  Diarrhoea (49),  Interstitial Lung Disease (47),  Anaemia (45),  Pancytopenia (37),  Neutropenia (34),  Pyrexia (33), more >>