A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
- Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with
stage IIIB or IV non-small cell lung cancer.
- Determine the efficacy markers of docetaxel and PI-88 in these patients.
- Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in
patients whose disease has been controlled with docetaxel and PI-88 combination
- Determine the safety and potential efficacy of PI-88 alone as third-line therapy in
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive docetaxel as in arm I. Patients also receive PI-88
subcutaneously once daily on days 1-4, 8-11, and 15-18.
In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Patients in arm II with stable or responding disease
after 6 courses may continue to receive PI-88 alone as maintenance therapy. Patients in arm
I with progressive disease or unacceptable toxicity before the completion of 6 courses may
receive PI-88 alone as third-line therapy.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
Nick Pavlakis, MD
Royal North Shore Hospital
United States: Federal Government