Short-Term Fasting in Reducing Side Effects in Patients Receiving Gemcitabine Hydrochloride and Cisplatin for Advanced Solid Tumors
This partially randomized pilot clinical trial studies short-term fasting in reducing side effects in patients receiving gemcitabine hydrochloride and cisplatin for solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment. Short-term fasting before chemotherapy may reduce the side effects caused by chemotherapy. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- 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
- Adequate renal function (creatinine =< 1.25 upper limit of institutional normal [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
- Diabetes mellitus
- 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
Locations & Contacts
Contact: Tanya Barauskas Dorff
Phone: 323-865-3905 Email: firstname.lastname@example.org
Trial Objectives and Outline
I. To determine the safety and feasibility of short-term fasting prior to administration of combination chemotherapy with platinum in patients with advanced solid tumor malignancies.
II. To evaluate the toxicity profile of platinum-based chemotherapy in subjects who eat normally compared to those who undertake short-term starvation.
III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1) and IGF binding protein (IGFBP) levels, and oxidative stress markers in subjects who undertake short-term fasting compared to controls.
IV. To investigate whether changes in glucose-regulated protein, 78kDa (grp78) expression occur after fasting and after chemotherapy administration in human subjects.
STAGE I: Patients are assigned to 1 of 4 treatment groups.
GROUP I: Patients fast for 24 hours on day -1.
GROUP II: Patients fast for 48 hours on days -2 and -1.
GROUP III: Patients fast for 72 hours (48 hours before and 24 hours after chemotherapy) on days -3, -2, and -1.
GROUP IV: Patients undergo a modified 48-hour fast with minimal caloric intake on days -2 and -1.
STAGE II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive the fasting regimen as in Group III of Stage I.
ARM II: Patients proceed to chemotherapy without fasting.
All patients receive gemcitabine hydrochloride intravenously (IV) on days 1 and 8 and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Trial Phase & Type
No phase specified
USC / Norris Comprehensive Cancer Center
Tanya Barauskas Dorff
Secondary IDs NCI-2010-00357, HS-09-00010
Clinicaltrials.gov ID NCT00936364