CURRENT ALIMTA (PEMETREXED) CLINICAL TRIALS

As a single agent, Alimta is indicated for the treatment of patients with locally or metastatic (spreading) non-small cell lung cancer, following prior chemotherapy treatments. When used in combination with platinum-based cisplatin, Alimta is the only FDA-approved drug for the specific treatment of malignant mesothelioma.

Alimta, also known by its generic drug name pemetrexed, is currently being tested in combination with various treatment modalities. Alimta-based clinical trials aimed at treating mesothelioma include:

  1. Alimta plus gemcitabine (Gemzar)
  2. Pemetrexed disodium and either gemcitabine or carboplatin
  3. Pemetrexed disodium and cisplatin, followed by surgery and radiation therapy
  4. Neoadjuvant pemetrexed disodium and cisplatin, followed by surgery and radiation therapy

The goal of each of these trials is to determine whether Alimta in combination with other types of drugs and other types of treatment (i.e. surgical or radiation) can provide for improved survivability for mesothelioma patients.

1. Alimta and Gemcitabine (Gemzar)

Gemcitabine is a nucleoside that is used in chemotherapy to cause programmed cell death (apoptosis) of malignant tumor cells. Gemcitabine is currently being tested in conjunction with Alimta for the treatment of patients with malignant pleural or peritoneal mesothelioma.

Phase II of the Alimta and gemcitabine clinical trial has four distinct goals:

  • Studying the safety of Alimta and gemcitabine and any side effects that might result from their combination.
  • Determining whether or not Alimta and gemcitabine can help mesothelioma patients live longer.
  • Determining whether or not Alimta and gemcitabine can reduce or destroy tumor cells.
  • Determining whether the Alimta and gemcitabine combination makes mesothelioma patients feel better.

2. Pemetrexed Disodium and Either Gemcitabine or Carboplatin

Carboplatin is a type of platinum-based chemotherapy drug. Pemetrexed disodium, carboplatin and gemcitabine all work in different ways to slow the growth of and kill tumor cells. It is believed that combining such chemotherapy drugs will help to kill more cancer cells; however, it is not known whether the combination of pemetrexed disodium and gemcitabine, or the combination of pemetrexed disodium and carboplatin, would be more effective against cancer cells. The purpose of this clinical trial is to determine whether Alimta in combination would be more effective.

Phase II of this clinical trial is randomized, meaning that patients will be randomly assigned into one of two groups:

Group 1: patients receive one infusion of pemetrexed disodium and carboplatin in week one. Treatment may repeat every third week for up to 18 weeks.

Group 2: patients receive one infusion of pemetrexed disodium and gemcitabine in week one. Patients receive another infusion of gemcitabine in week two. Treatment may repeat every third week for up to 18 weeks.

3. Pemetrexed Disodium & Cisplatin

Cisplatin is a platinum-based chemotherapy drug used in the treatment of small-cell lung cancer, ovarian cancer, lymphomas and germ cell tumors. Cisplatin was the first in a class of three platinum-based drugs that now includes carboplatin and oxaliplatin.

The combination of cisplatin and pemetrexed disodium with high-dose postoperative radiation therapy is currently in phase II of its clinical trial.

Patients are treated intravenously with pemetrexed disodium and cisplatin. This infusion process is repeated every three weeks (maximum of nine weeks). Following completion of the chemotherapy treatment, patients might have surgery to remove the tumor. Between one and three months after the surgery, patients might undergo radiotherapy treatment (everyday for a month) to kill any remaining tumor cells.

4. Neoadjuvant Pemetrexed Disodium & Cisplatin

This clinical trial is very similar to the aforementioned pemetrexed disodium and cisplatin treatment. Patients are treated intravenously with pemetrexed disodium and cisplatin. This infusion process is repeated every three weeks (maximum of 12 weeks).

Following completion of the chemotherapy treatment, patients will undergo an extrapleural pneumonectomy, the removal of an entire lung. Between one and three months after the surgery, patients might undergo radiotherapy treatment (everyday for a month) to kill any remaining tumor cells.

Currently in phase II of the clinical trial, the neoadjuvant pemetrexed disodium & cisplatin chemotherapy with extrapleural pneumonectomy and postoperative radiotherapy procedure is being tested for the treatment of stage I, stage II and stage III pleural mesothelioma.

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