The anticancer efficacy of the Gonzalez regimen has been investigated in two human studies (CPMC-IRB-8544), 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]
   
   

Back to Top

< Previous Section  |  Next Section >