Short-Term Fasting Prior To Platinum-based Chemotherapy: Feasibility and 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 (metastatic) 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 1 cycle 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.