drugset / Trial / NCT00901537

Azacitidine and Cisplatin in Patients With Advanced Lung or Head and Neck Cancer

NCT00901537 ↗

Phase 1 Terminated 8 enrolled Loma Linda University
NaSingle-groupOpen-labelTreatment

Summary

The standard of care for head and neck and lung cancer includes chemotherapy, radiation and surgery. For patients with cancer of head and neck or lung that recurs after surgery and/or radiation, or has spread to other parts of body, chemotherapy using cisplatin can slow down tumor growth and extend lifespan. The study drug, azacitidine, can block the ability of some cancer cells to replicate, and has been approved by the Food and Drug Administration for use in myelodysplastic syndrome, which is a slowly developing blood cell-related cancer. In laboratory and animal experiments using head and neck and lung cancer cells, azacitidine has been shown to be a cisplatin "helper", (that is, it makes cisplatin more effective in stopping the growth of head and neck and lung cancer. ) Since the combination of azacitidine and cisplatin has not been used in patients with head and neck or lung cancer, the investigators are performing this study combining azacitidine and cisplatin to find out what effects, good and/or bad, the study drug may have on patients with advanced head and neck or lung cancer. The investigators are doing this study because they would like to find a better treatment for these types of cancer.

Timeline

Start
2009-02
Primary completion
2011-09
Completion
2011-10

Outcome

Outcome not reported

Stopped (Enrollment): “Sponsor terminated due to no enrollments within last 4 months.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 37 mg/m2 Subcutaneous
Subject Azacitidine Other / unclassified 60 mg/m2 Subcutaneous
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Azacitidine Other / unclassified 85 mg/m2 Subcutaneous
Subject Azacitidine Other / unclassified 100 mg/m2 Subcutaneous
Subject Azacitidine Other / unclassified 110 mg/m2 Subcutaneous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous