Short-Term Fasting Prior To Platinum-based Chemotherapy: Feasibility and Impact on Toxicity
I. To determine the safety and feasibility of short-term fasting prior to administration of
combination chemotherapy with platinum in patients with advanced solid tumor malignancies.
II. To evaluate the toxicity profile of platinum-based chemotherapy in subjects who eat
normally compared to those who undertake short-term starvation.
III. To investigate changes in plasma insulin, glucose, IGF1 and IGF binding protein (IGFBP)
levels, and oxidative stress markers in subjects who undertake short-term fasting compared
IV. To investigate whether changes in grp78 expression occur after fasting and after
chemotherapy administration in human subjects.
STAGE I: Patients are assigned to 1 of 4 treatment groups. GROUP I: Patients fast for 24
hours on day-1.
GROUP II: Patients fast for 48 hours on days -2 and -1.
GROUP III: Patients fast for 72 hours on days -3, -2, and-1.
GROUP IV: Patients undergo a modified 48-hour fast with minimal caloric intake on days -2
STAGE II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients fast for 72 hours on days -2, and on day 1.
ARM II: Patients proceed to chemotherapy without fasting.
All patients receive gemcitabine hydrochloride intravenously (IV) on days 1 and 8 and
cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 4 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Identification of the longest duration of fasting which is safe
Up to 5 years
Tanya Dorff, MD
USC/Norris Comprehensive Cancer Center
United States: Institutional Review Board
|USC/Norris Comprehenseive Cancer Center||Los Angeles, California 90033|