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NEW YORK, Aug. 21, 2014 /PRNewswire/ -- Bruckner Oncology has initiated an FDA approved Phase II-III clinical trial which adds Vitamin C to chemotherapy "core" regimens (GFLIO and GFLIO-D) for patients with locally advanced and metastatic pancreatic cancer (APC).
Vitamin C was selected for study because there has never been a formal clinical trial of this frequently used, off label vitamin which has long been credited with improving safety and quality of life during chemotherapy. Also, many investigators found Vitamin C improved the effectiveness of specific chemotherapy for specific (not all) tumors under laboratory conditions. A successful test could benefit the nearly 50% of patients with APC and other cancers who now go untreated or undertreated because of safety and efficacy concerns.
SAFETY: The trial will attempt to reproduce the practice's pilot trial in which Vitamin C and the concurrent cores produced a less than one percent rate of clinically significant adverse events. The pilot group had many high risk patients. During Vitamin C co-treatment patients with preexisting symptoms and adverse events safely tolerated treatment and many improved. Standard treatments produce 10%-40% rates of clinically significant severe adverse events, in trials limited to ideal low risk patients.
SURVIVAL: The trial's secondary objective is to reproduce ten years of APC development experience with the cores. Median survival for prior patients with advanced pancreatic cancer including high risk patients, was 16 - 24 months (ASCO 2008, 2012, and 2013), high risk patients, often untreated elsewhere, are eligible for safe treatment with cores including the elderly, the prior treated and those with a poor 2-3 performance status (ASCO 2008). Current standard regimens in trials limited to ideal low risk patients produce MSTs of less than 12 months.
The core regimens were selected as the control because past experience suggests they may provide one of the safest treatment strategies for important anti-cancer drug classes. There are potential lessons applicable to other cancers because the cores also appear to improve the performance of these drugs for other gastrointestinal, ovarian and uterine cancers (ASCO 2006, 2012, AACR 2014).
The core by its novel design attempts to either double or triple the chances to achieve favorable anti-cancer drug interactions, reverse drug resistance and chances for Vitamin C to impact anti-tumor efficacy compared to standard regimens.
The novel trial design allows every patient the early use of Vitamin C and to continue Vitamin C without interruption when there is evidence of benefit.
The investigators caution that this information should not be taken as a general recommendation for use of Vitamin C. Management of Vitamin C requires special monitoring and maintenance of dosage. Vitamin C may not be suitable for combination with some (other) drugs, nor be an effective protectant for standard regimens which produce high rates of severe adverse events. The trial is supported by a grant from The Marcus Foundation.
Howard W. Bruckner MD, Medical Director
MZB Foundation for Cancer Research, Medical Director
SOURCE Bruckner Oncology