There was a significant development in the treatment of mesothelioma in February 2004 when the Food and Drug Administration (FDA) approved the chemotherapy drug Alimta for mesothelioma patients. The FDA found that Alimta was effective in treating mesothelioma in combination with Cisplatin, another chemotherapy drug. The Alimta/Cisplatin combination is now considered the front-line chemotherapy in the treatment of this aggressive cancer.

Since the 1970s, may clinical trials have been conducted by researchers to find chemotherapy drugs to combat mesothelioma. So far, none of the drugs that were tested before Alimta had any significant impact. Doctors have treated patients with Cisplatin, an existing chemotherapy drug, and found that patients survived an average of nine months from diagnosis. However, with the combination of Cisplatin and Alimta, patients survive 30 percent longer than when they were treated with Cisplatin alone. Doctors have found that patients live longer with less pain and less shortness of breath when on this chemotherapy regimen.

Active and Recruiting Clinical Trials Involving Alimta

To find more effective treatments for mesothelioma, researchers conduct clinical trials which test different combinations of chemotherapy drugs. The purpose of these studies is to determine which therapies are effective and at what dose. For example, some studies have combined Alimta with Carboplatin instead of Cisplatin, as it has been shown to have less adverse side effects for patients. Gleevec and Gemcitabine are two other chemotherapy drugs currently being tested in clinical trials to determine their effectiveness in combination.

Presently there are Active and Recruiting Phase I clinical trials in which Alimta and other chemotherapy drugs are being combined and tested to find more effective treatments for mesothelioma. Once researchers find that a drug combination appears promising, Phase II clinical trials are conducted. There are many Phase II trials involving Alimta and other chemotherapy drugs presently underway.

Treatment With Alimta

Alimta is typically administered along with Cisplatin since this combination of drugs has been found to be effective in treating mesothelioma in some patients. These drugs are administered intravenously on an outpatient basis, so no hospitalization is required. The entire treatment usually takes about two and a half hours.

After your body has received this treatment, known as a cycle, you will not have another treatment for 20 days so your healthy cells have time to replenish themselves. Your doctor will determine the number of cycles of treatment that are best for you, as there is no pre-determined number.

Side Effects

While Alimta has proven to successfully shrink tumors, it does not come without adverse side effects. Patients under Alimta therapy can potentially experience low blood cell counts, mental fatigue, nausea and vomiting, diarrhea, loss of appetite and skin rash. To fight these side effects, patients are often advised to take vitamin B-12 and folic acid supplements.

History of Alimta’s FDA Approval

The 2002 clinical studies conducted at the National Cancer Institute (NCI) examined the effects of the drug Pemetrexed, later named Alimta. The studies found that this drug was more effective when used in combination with other chemotherapy drugs. It was found that tumors shrank in 41% of patients on Pemetrexed in combination with Cisplatin. Only 17% of patients receiving Cisplatin alone experienced tumor shrinkage.

Pemetrexed, a molecular structure developed by Edward C. Taylor at Princeton University, works by inhibiting the formation of DNA and RNA, both of which are required for the growth of normal and cancerous cells. Pemetrexed was clinically developed by Eli Lilly and Company in 2004 and introduced into the marketplace under the brand name “Alimta.” Pemetrexed, or Alimta, is in the class of chemotherapy drugs called folate antimetabolites. Folate antimetabolites are drugs that impair the function of folic acids. Alimta and other similar antimetabolites work by inhibiting three enzymes used in purine and pyrimidine synthesis. By inhibiting this synthesis, Alimta prevents DNA and RNA formation and ultimately leads to the death of cancer cells.

Alimta was recently FDA approved for use against non-small cell lung cancer. While patients are on the Alimta therapy they are required to take additional supplements of folic acid and vitamin B12. These supplements have been proven to reduce adverse side effects of Alimta.