Short-Term Fasting in Reducing Side Effects in Patients Receiving Chemotherapy for Advanced Solid Tumors

Inclusion Criteria

• Histologically confirmed solid tumor malignancy for which platinum-based chemotherapy on a 21-day cycle or 14 day cycle is being recommended
• 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: evaluable disease by Response Evaluation Criteria in Solid Tumors (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
• Stage I: subjects may have already received no more than 2 cycle of their 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 more than 1 prior chemotherapy regimen for metastatic disease; and no more than 2 cycles of their current platinum chemotherapy regimen for metastatic disease; they must have recovered to =< grade 1 from all toxicities related to the prior chemotherapy; patients who have received perioperative (i.e. adjuvant or neoadjuvant therapy) > 1 year prior to being treated with chemotherapy for metastatic disease will be eligible provided any chemotherapy-related toxicity has recovered to specified levels
• Prior radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment
• Body mass index (BMI) >= 18.5
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Creatinine =< 1.5 upper limit of institutional normal (ULIN) or calculated creatinine clearance > 40 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 * Note: subjects with pre-diabetes or a history of diabetes which subsequently resolved, who are not taking metformin or any other diabetes medication are eligible
• Subjects with 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, for instance
• Peripheral neuropathy >= grade 1
• History of significant cardiac disease, particularly uncompensated congestive heart failure New York Heart Association (NYHA) grade 2 or more or left ventricular ejection fraction (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-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