PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER
OBJECTIVES: I. Estimate the maximum tolerated dose of hydroxyurea that can be given in
combination with other chemotherapy regimens in patients with incurable non-small cell lung
cancer. II. Determine the toxicity of this combination chemotherapy regimen in these
patients. III. Observe the efficacy of hydroxyurea in patients with incurable non-small cell
lung cancer refractory to front-line chemotherapy.
OUTLINE: This study seeks to estimate the maximum tolerated dose (MTD) of hydroxyurea in
combination with other chemotherapy. Groups of 3 patients take escalated doses of oral
hydroxyurea three times weekly or daily throughout treatment with cisplatin plus (per their
previous regimen) vinblastine, vindesine, vinorelbine, or etoposide. Treatment continues in
responding and stable patients until 3 months beyond documentation of complete remission
(minimum 4 courses), maximum of 6 courses beyond documentation of partial remission, or 3
courses beyond documentation of stable disease. Patients are followed every 3 weeks for 3
months, every 6 weeks for 3 months, then every 3 months until disease progression.
PROJECTED ACCRUAL: An anticipated 15-30 patients will be entered.
Primary Purpose: Treatment
David J. Stewart, MD, FRCPC
Ottawa Regional Cancer Centre
United States: Federal Government