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., Francisco Acosta, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Histologically confirmed solid tumor for which platinum-based chemotherapy on a 21-day cycle or 14-day cycle is being recommended
2	At least 18 years of age
3	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.
4	Prior 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.
5	Prior RT: allowed, provided at least 2 weeks have elapsed from completion of RT to initiation of protocol treatment
6	BMI = / > 20.5
7	ECOG performance status 0-1
8	Creatinine < / = 1.25 x uln or calculated CrCl >50 ml/min
9	Pre-menopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
10	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	Diabetes mellitus
2	Weight loss >10% of body weight in the year prior to planned chemotherapy
3	Peripheral neuropathy > / = Gr 1
4	History of significant cardiac disease, particularly uncompensated CHF NYHA Gr 2 or more or LVEF < 40% on any prior assessment.
5	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
6	History 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.