Innovative Clinical Trial for Patients With Advanced Pancreatic Cancer

An innovative clinical trial to be conducted at ColumbiaUniversity in New York City for people diagnosed with advanced pancreatic cancer is now recruiting patients. The volunteer patients will test the effectiveness of what is called “the Gonzalez regimen,” which combines a strict diet of fresh fruits, vegetable juices, dietary supplements, and pancreatic enzyme extracts, plus a “detoxification” program.

John Chabot, MD, a surgical oncologist at Columbia, is the trial's principal investigator. From 72 to 90 patients with advanced pancreatic cancer are being sought for the phase III study, which is being sponsored by the National Cancer Institute’s (NCI) newly established Office of Cancer Complementary and Alternative Medicine. Half of the patients will receive standard therapy with gemcitabine (Gemzar), while the other half will follow the Gonzalez regimen.

The Gonzalez Regimen

With this rigorous diet, patients eat large amounts of raw fruits, raw and steamed vegetables, juices, cereals, and nuts, including up to 20 almonds a day. Fish is allowed in limited quantities. The diet excludes red meat, chicken, refined grain products, white sugar, and soy.

Patients also take approximately 150 pills a day, at regular intervals throughout the day, on an empty stomach. The pills include vitamins, minerals, amino acids, trace elements, glandular extracts, and 25 to 40 g (40 pills) of freeze-dried pancreatic enzymes derived from pigs. Most patients take the pills for 15 days, stop for 5 days, and begin again.

During the 5-day break, patients undergo a “detoxification” process: they can use coffee enemas; or drink fruit juices or a Metamucil-like product in conjunction with various herbs to flush out their systems. The cost of the regimen is approximately $6,000 per year, but the cost is being funded by the NCI and the pills are supplied free of charge.

The trial, which was given a 5-year, $250,000 grant, is applying scientific methods to assess the efficacy of this alternative treatment. The NCI agreed to test the regimen after Nicholas Gonzalez, MD, a New York endocrinologist, conducted a pilot study of his protocol from 1993 to 1996. The results, reported earlier this year in Nutrition and Cancer, showed that 9 of 11 pancreatic patients survived for 1 year, 5 patients survived for 2 years, and 4 patients survived for 3 years. These results surpassed those usually achieved with standard treatment for advanced pancreatic cancer.

Protocol Based on Embryologist's Observation

The Gonzalez protocol derives from the work of John Beard, a turn-of-the-century Scottish embryologist who noted that placentas, which invade the uterus much as a tumor does, stop growing the day that the fetal pancreas begins to function. Thus, Beard theorized that pancreatic enzymes might also halt the growth of malignant tumors.

For information about patient entry into the trial, contact Michelle Gabay, rn (212-305 9468), at New York Presbyterian–The University Hospital of Columbia and Cornell.