The National Cancer Institute (NCI) has launched a large, randomized clinical trial to test the effects of shark cartilage in combination with chemotherapy and radiotherapy in patients with non-small cell lung cancer (NSCLC) that cannot be removed by surgery. The study will take place at more than 50 sites throughout the United States and Canada and seeks to enroll 756 patients over the next three years.

The primary objective of this trial is to determine if chemotherapy plus radiation therapy is more effective when combined with shark cartilage extract for the treatment of non-small cell lung cancer. It is expected that the results from this trial will be available in approximately five years.

The shark cartilage extract is called Neovastat, or AE-941, and is manufactured by Aeterna Laboratories, Quebec, Canada. Neovastat has been shown in preclinical studies to shrink or slow the growth of NSCLC tumors. Neovastat has antiangiogenic properties it prevents tumor cells from forming new blood vessels necessary for their growth and development.

"The preclinical data for AE-941 support antiangiogenic and antimetastatic activity," said principal investigator Charles Lu, M.D., of the M. D. Anderson Cancer Center in Houston. "In addition, the results of earlier clinical data suggest a potential survival benefit in non-small cell lung cancer patients."

Researchers conducting this study hope to learn if there is a difference in survival time and in tumor response between those patients who are given the shark cartilage and those who are not. "We are pleased that accrual has begun for this exciting, pivotal, NCI-sponsored trial," said Lu.

There is an urgent need for improved treatments for patients with locally advanced NSCLC (referred to as stage IIIA or IIIB). It is estimated that 169,000 people will be diagnosed with lung cancer in 2001, and approximately 80 percent of those people will have NSCLC. For the 30 percent of NSCLC patients who are diagnosed with locally advanced disease, the average survival time is around 12 months.

This randomized, Phase III study will have two treatment arms, with 378 participants per arm. One group will receive standard chemotherapy (either cisplatin and vinorelbine, or carboplatin and paclitaxel) and radiation, in addition to the Neovastat. The other group will receive standard chemotherapy, radiation and a placebo (an inactive drink that looks like Neovastat). Giving patients either the drug or a placebo, in a manner known as "double blinding" (neither the doctors nor the patients know whether the patients are receiving the drug or the placebo), allows the researchers to clearly determine whether there are benefits and/or associated side effects with the cartilage extract

Neovastat is a water extract of dogfish shark cartilage, which is then frozen in 120 milliliter bottles. Participants in the study thaw two bottles daily, shaking the medication and swallowing the entire contents of a bottle approximately every 12 hours. In studies conducted thus far, the extract has had very minimal side effects, with only a minority of patients experiencing minor nausea or other gastrointestinal discomfort.

To be eligible for the study, patients must have a measurable lesion, a confirmed diagnosis of inoperable non-small cell lung cancer stage IIIA or IIIB, and be candidates for chemotherapy and radiotherapy. Since Neovastat is a liquid extract of shark cartilage, patients allergic to fish products cannot participate in the study.

For more information on this and other clinical trials, patients and physicians may visit NCI's Web site for clinical trials, http://cancertrials.nci.nih.gov, or may call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The number for callers with TTY equipment is 1-800-332-8615.

To inquire about enrollment in the study, patients or physicians may also call the M. D. Anderson Cancer Center toll-free at 1-800-392-1611.

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