The anticancer efficacy of the Gonzalez regimen has been investigated in two human studies (CPMC-IRB-8544 ¹), both involving patients with pancreatic cancer.

The first study, a prospective nonconsecutive case series conducted by the developer and an associate, included 11 patients diagnosed with adenocarcinoma of the pancreas (stage II or stage IV). None of the patients had received chemotherapy or radiation therapy, and none had undergone surgical resection with curative intent. All the patients had pancreatic tumors that were either unresected or partially resected. Survival from the time of diagnosis was the only study endpoint, and all 11 patients (including one who left the study) were included in this survival analysis.

The investigators reported a median survival time of 17 months and a mean survival time of 25.2 months for these patients. Nine patients (82%) survived 1 year, five patients (45%) survived 2 years, and four patients (36%) survived 3 years. At the time the study was reported, two patients were alive: one who had survived 3 years, and one who had survived 4 years. The researchers concluded that the 1-year and 2-year survival percentages for this group of patients were superior to those observed for other U.S. patients diagnosed with adenocarcinoma of the pancreas (1-year survival, all stages = 25%; 2-year survival, all stages = 10%).[1]

The small number of patients in this study and the absence of a control group are limitations that raise doubts about the reliability of its findings. It is possible that important, unidentified differences between these patients and other patients diagnosed with stage II to stage IV pancreatic cancer contributed to the relatively long survival. The investigators report that 25 additional patients with pancreatic cancer were seen during the study period but were excluded from study participation. Eleven of these patients were excluded on the basis of comorbidities, previous treatment, or delay between diagnosis and beginning the program; 14 otherwise eligible patients were excluded on the grounds that they chose not to start the program, complied only briefly, or predicted noncompliance.[1]

The second study is a nonrandomized prospective case-controlled phase III clinical trial (CPMC-IRB-8544) sponsored by the National Center for Complementary and Alternative Medicine and the National Cancer Institute in which survival and quality of life are being compared between patients treated with the Gonzalez regimen and patients treated on other clinical trials with gemcitabine -based (i.e., other drugs may be included) chemotherapy. Up to 90 patients with inoperable stage II, III, or IV adenocarcinoma of the pancreas are planned for accrual. This study was originally planned for randomization but changed after few patients elected to participate in the randomized trial. The patients in both groups of the current trial must meet the same eligibility criteria. This study is still ongoing.

No data concerning the effectiveness of the Gonzalez regimen for the treatment of cancer patients with other types of cancer have been reported, despite claims that a variety of cancers can be treated. In addition, there is no safety or efficacy information on the regimen in children. No clinical trials of this regimen have been conducted in children, and this extremely difficult regimen may be prohibitive in young children.

References

1. Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 33 (2): 117-24, 1999.  [PUBMED Abstract]
   
   

Glossary Terms

Cancer that begins in cells that line certain internal organs and that have gland-like (secretory) properties.

A process in which anything complex is separated into simple or less complex parts.

Treatment with drugs that kill cancer cells.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.

The process of identifying a disease, such as cancer, from its signs and symptoms.

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

Effectiveness. In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect.

In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.

In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor.

A drug that is used to treat certain types of breast cancer, pancreatic cancer, ovarian cancer, and lung cancer and is being studied in the treatment of other types of cancer. Gemcitabine is a type of antimetabolite. Also called gemcitabine hydrochloride and Gemzar.

An alternative therapy that is being studied as a treatment for pancreatic cancer. It includes a special diet, nutritional supplements, pancreatic enzymes, and coffee enemas.

Describes a condition that cannot be treated by surgery.

The average time that patients in a clinical study remained alive. The time is measured beginning either at diagnosis or the start of treatment.

The time from either diagnosis or treatment at which half of the patients with a given disease are found to be, or expected to be, still alive. In a clinical trial, median survival time is one way to measure how effective a treatment is.

The National Cancer Institute, part of the National Institutes of Health of the United States Department of Health and Human Services, is the Federal Government's principal agency for cancer research. The National Cancer Institute conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the National Cancer Institute Web site at http://www.cancer.gov. Also called NCI.

A clinical study that includes some, but not all, of the eligible patients identified by the researchers during the study registration period. This type of study does not usually have a control group.

Closely monitoring a patient's condition but withholding treatment until symptoms appear or change. Also called active surveillance, expectant management, and watchful waiting.

A glandular organ located in the abdomen. It makes pancreatic juices, which contain enzymes that aid in digestion, and it produces several hormones, including insulin. The pancreas is surrounded by the stomach, intestines, and other organs.

Having to do with the pancreas.

A disease in which malignant (cancer) cells are found in the tissues of the pancreas. Also called exocrine cancer.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

In medicine, a study or clinical trial in which participants are identified and then followed forward in time.

The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.

When referring to an experiment or clinical trial, the process by which animal or human subjects are assigned by chance to separate groups that compare different treatments or other interventions. Randomization gives each participant an equal chance of being assigned to any of the groups.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

Removed by surgery.

A procedure that uses surgery to remove tissue or part or all of an organ.

The extent of a cancer in the body. Staging is usually based on the size of the tumor, whether lymph nodes contain cancer, and whether the cancer has spread from the original site to other parts of the body.

An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancerous), or malignant (cancerous). Also called neoplasm.

Describes an organ, tissue, or cancer that has not been either partly or completely removed by surgery.