Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells.
PURPOSE: Phase I trial to study the effects of hydroxyurea plus combination chemotherapy in patients with non-small cell lung cancer.
Drug: vinblastine sulfate
Drug: vinorelbine tartrate
Procedure: drug resistance inhibition treatment
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER|
|Study Start Date:||July 1995|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002887
|Ottawa Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 1C4|
|Study Chair:||David J. Stewart, MD, FRCPC||Ottawa Regional Cancer Centre|