Phase I Study of Azacitidine in Combination With Cisplatin in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer or Squamous Cell Carcinoma of the Head and Neck
Azacitidine will be given with standard dose of cisplatin. At the beginning of the study,
three patients will be treated with low dose of azacitidine. If that dose does not cause
bad side effects, then the dose will slowly be made higher for new patients who take part in
Patients will receive azacitidine as a once-a-day subcutaneous (under the skin) injection
every day from day 1 to day 5 of 28 days in this study. Cisplatin is given intravenously on
day 8. This 28-day or 4-week period of time is called a cycle. Cycles are repeated every
four weeks for as long as the physician recommends.
During this study, patients will need the following tests and procedures.
- Physical exam - This will be done weekly during first 2 weeks of every 4-week
- Blood tests for blood counts - These will be done every week.
- Blood tests for kidney function, liver function, and to measure electrolytes - These
will be done every week
- Blood samples for research study - This will be done weekly during first cycle, then
weekly during the first 2 weeks on the subsequent treatment cycles
- X-rays or scans - These will be done once every 8 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety and toxicity of azacitidine and cisplatin combination.
weekly for first 4 weeks, then weekly times 2 for every 4 weeks
Chung-Tsen Hsueh, MD, PhD
Loma Linda University Cancer Center
United States: Institutional Review Board
|Loma Linda University Cancer Center||Loma Linda, California 92354|