Short-Term Fasting: Impact on Toxicity

Inclusion Criteria:

• Age > 18 years
• Histologically confirmed malignancy for which platinum-based chemotherapy on a 21 day cycle or 14 day cycle is being recommended.

• Disease state:

  • Stage I of the trial: newly diagnosed disease for which neoadjuvant or adjuvant chemotherapy is planned in the curative setting, or metastatic disease.
  • Stage II of the trial: Measurable disease by RECIST criteria must be present for all subjects in the randomized component of the trial- if surgery or radiation is planned, the target lesions may not be so treated until after the assessment of the effect of chemotherapy.

• Prior chemotherapy

  • Stage I: subjects may have already received no more than 2 cycle of platinum-based chemotherapy, but should not have received other prior chemotherapy regimens with the exception of patients with metastatic disease who received neoadjuvant or adjuvant chemotherapy and that chemotherapy was completed > 6 months prior to enrollment.
  • Stage II: subjects must have received no prior chemotherapy regimens for metastatic disease, and no more than 2 cycles of their current platinum chemotherapy regimen for metastatic disease. They may have received prior neoadjuvant or adjuvant chemotherapy, provided such therapy was completed >6 months prior to enrollment.
• Prior Radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment.
• BMI > 18.5
• ECOG performance status 0-1
• Adequate renal function (Creatinine <1.25 ULIN or calculated creatinine clearance > 50 ml/min)
• Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period.

Exclusion Criteria:

• Diabetes Mellitus
• Recent significant or unexplained weight loss that the investigator feels may pose an unacceptable risk for enrollment. Candidates who are overweight and have lost weight intentionally via diet or exercise should not be excluded.
• Peripheral Neuropathy > grade 1
• History of significant cardiac disease, particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40% on any prior assessment. (Assessment of LVEF prior to therapy is not required in the absence of other clinical indicators of heart disease). Patients with a prior LVEF <40% will require re-evaluation prior to study entry.
• Subjects on medications that may not be safely stopped during the fasting portion of the study, or which may not be safely consumed without food.
• A history of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous.