Glufosfamide With of Without Hydration in Treating Patients With Advanced Non-small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with saline solution may protect kidney cells from the side effects of chemotherapy.
PURPOSE: Randomized phase II trial to study the effectiveness of glufosfamide with or without hydration in treating patients who have advanced non-small cell lung cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Non Small Cell Lung Cancer|
|Study Start Date:||January 2000|
|Primary Completion Date:||March 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005055
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Study Chair:||Pierre Fumoleau, MD, PhD||Centre Georges Francois Leclerc|