Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Non Small Cell Lung Cancer
OBJECTIVES: I. Determine the activity of glufosfamide as determined by objective response in
patients with non-small cell lung cancer. II. Determine the response rate in this patient
population after this treatment. III. Determine the duration of objective response in these
patients treated with this drug. IV. Characterize the toxicities of this drug in these
patients. V. Assess the impact of the hydration scheme on the toxicity profile (renal
function) of this drug in these patients. VI. Assess the pharmacokinetic profile of this
drug in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to
receive glufosfamide with or without hydration. Arm I: Patients receive glufosfamide IV over
1 hour every 3 weeks. Arm II: Patients receive glufosfamide as in arm I. Patients are
hydrated with excess physiological saline solution 4 hours before and 3 hours after
treatment with glufosfamide. Treatment in both arms continues for 2-6 courses in the absence
of unacceptable toxicity or disease progression. Patients with an objective complete
response continue treatment for a maximum of 2 courses after the confirmation of response.
Patients are followed every 6 weeks until disease progression.
PROJECTED ACCRUAL: A total of 16-32 patients (8-16 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Pierre Fumoleau, MD, PhD
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
United States: Federal Government