University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 0S-08-9


Short-Term Fasting Prior to Platinum-Based Chemotherapy: Feasibility and Impact on Toxicity.

Type: Supportive Care
Phase: Phase I/II
Status: Open to Accrual
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Tanya Dorff, M.D.
Other Trial Staff:  Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Kristy Sartor Massopust, Coordinator, America Casillas-Lopez, Coordinator, Ernesto Duverger, D.M.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Histologically confirmed solid tumor for which platinum-based chemotherapy on a 21-day cycle or 14-day cycle is being recommended
2At least 18 years of age
3Disease 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.
4Prior chemotherapy: Stage I: subjects may have already received no more than 2 cycles 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: chemotherapy-naïve for metastatic disease. May have received prior neoadjuvant or adjuvant chemotherapy, provided such therapy was completed >6 months prior to enrollment.
5Prior RT: allowed, provided at least 2 weeks have elapsed from completion of RT to initiation of protocol treatment
6BMI = / > 20.5
7ECOG performance status 0-1
8Creatinine < / = 1.25 x uln or calculated CrCl >50 ml/min
9Pre-menopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
10Signed an approved study-specific informed consent and HIPAA


You may not participate in this study if:
1Diabetes mellitus
2Weight loss >10% of body weight in the year prior to planned chemotherapy
3Peripheral neuropathy > / = Gr 1
4History of significant cardiac disease, particularly uncompensated CHF NYHA Gr 2 or more or LVEF < 40% on any prior assessment.
5Subjects on medications that may not be safely stopped during the fasting portion of the study, or which may not be safely consumed without food
6History of syncope with calorie restriction in the past or other medical co-morbidity, which would make fasting potentially dangerous



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.