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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. Assess the impact of food on the bioavailability of Ro 31-7453 in patients with locally advanced or metastatic solid tumors.
OUTLINE: This is a randomized, crossover study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral Ro 31-7453 under fasting conditions on day 1. After a 1-week washout period, patients receive oral Ro 31-7453 under fed conditions. Arm II: Patients receive fed treatment as in arm I on day 1. After a 1-week washout period, patients receive fasted treatment as in arm I. Both arms: At the start of week 3, patients may continue to receive oral Ro 31-7453 every 12 hours on days 1-4. Treatment repeats every 3 weeks for at least 24 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 7 days.
PROJECTED ACCRUAL: A total of 10 patients (5 per arm) will be accrued for this study.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:00-0400
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Diseases of the respiratory system in general or unspecified or for a specific respiratory disease not available.
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Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...
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