Alimta

Alimta (pemetrexed disodium) used in combination with cisplatin was approved by the Food and Drug Administration in February of 2004 following eleven years of clinical trials.  Clinical trial testing demonstrated that when used as a single agent Alimta was effective in the treatment of non-small cell lung cancer with patients who had undergone prior chemotherapy regimens.  Additional testing demonstrated that when used in combination with platinum-based cisplatin (a traditional chemotherapy agent), Alimta is somewhat more effective in the treatment of patients suffering from malignant mesothelioma.

The Alimta plus cisplatin clinical trial yielded an increased median survival time for malignant mesothelioma sufferers by an approximate three months. Although by no means a curative treatment, Alimta has proven to be one of the more effective new drugs in producing positive results in the treatment of mesothelioma. As such, Alimta when used in combination with platinum-based cisplatin is the only FDA-approved drug for the specific treatment of malignant mesothelioma.

Alimta chemotherapy treatments generally follow a typical routine: Alimta is administered intravenously once every three weeks for a ten-minute period. In order to prepare the body for treatments with Alimta, a number of preparatory steps must be taken:

  • A folic acid pill must be taken every day, starting five to seven days before treatment begins, and continuing until 21 days after the last Alimta cycle has been completed.
  • An oral steroid must be taken twice a day on the day before, the day of, and the day after treatment. The oral steroid (typically dexamethasone) minimizes the risk of Alimta side effects.
  • Receive a vitamin B12 shot from a doctor. Another B12 shot will be received every nine months.

Current Alimta Clinical Trials

Although Alimta has already been approved by the FDA for the treatment of malignant mesothelioma, its clinical trial process is ongoing. Currently, there are a variety of clinical trials testing the safety and efficacy of Alimta in conjunction with a variety of other drugs and treatment modalities.

Ongoing Alimta-based clinical trials aimed at treating mesothelioma include:

  1. Alimta (pemetrexed disodium) plus gemcitabine (Gemzar)
  2. Alimta and either gemcitabine or carboplatin
  3. Alimta and cisplatin, followed by surgery and radiation therapy
  4. Neoadjuvant (drugs given before the main treatment which in this case is surgery and radiation therapy) Alimta and cisplatin, followed by surgery and radiation therapy

1. 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 be produced from a combination of the two.
  • Determining the efficacy of Alimta and gemcitabine in terms of mesothelioma survivability.
  • 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. Phase II of this clinical trial is randomized, meaning that patients will be randomly assigned into one of the following two groups:

Group 1:  Patients receive an infusion of pemetrexed disodium and an infusion of carboplatin in week one. This treatment may repeat every third week for up to 18 weeks.

Group 2: Patients receive one infusion of pemetrexed disodium and one infusion of 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. 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 a platinum-based chemotherapy drug called cisplatin. This infusion process is repeated every three weeks for a 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 to kill any remaining tumor cells.

4. 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.