Combination Chemotherapy 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Trial of Daily Oral ZD1839 (Iressa) With Standard Doses of Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer|
|Study Start Date:||September 1999|
|Study Completion Date:||March 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose of ZD 1839 given intermittently or continuously and concurrently with standard doses of carboplatin and paclitaxel in patients with advanced non-small cell lung cancer. II. Determine the safety of ZD 1839 in these regimens in these patients. III. Determine whether the exposure of either free carboplatin or paclitaxel in an established treatment regimen is significantly altered by the addition of oral ZD 1839 in this patient population. IV. Determine the exposure of ZD 1839 before and after standard doses of carboplatin and paclitaxel to assess whether ZD 1839 steady state is significantly altered by coadministration of chemotherapy.
OUTLINE: This is an open label, 2 part, multicenter study. Part 1 is a randomized, dose escalation, 2 period, 2 sequence, crossover design. Part 2 is a nonrandomized, single dose evaluation design. Part 1: Patients are randomized to receive ZD 1839 beginning 1 week before either the first (arm I) or second (arm II) course of carboplatin and paclitaxel. Arm I: Patients receive oral ZD 1839 daily on days 1-14. On day 1 only, ZD 1839 is given twice at 12 hour intervals. Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on days 8 and 36. Subsequent courses consist of ZD 1839 for 14 days and paclitaxel and carboplatin every 28 days. Arm II: Patients receive paclitaxel and carboplatin as in arm I on days 1 and 29. Patients receive oral ZD 1839 daily on days 22-35. On day 22 only, ZD 1839 is given twice at 12 hour intervals. Subsequent courses are administered as in arm I. Part 2: Patients receive oral ZD 1839 daily on days 1-56. On day 1 only, ZD 1839 is given twice at 12 hour intervals. Patients receive paclitaxel and carboplatin as in part 1 on days 8 and 36. Subsequent courses consist of ZD 1839 continuously and paclitaxel and carboplatin every 28 days. Treatment continues in both parts for a maximum of 6 months in the absence of unacceptable toxicity or disease progression. In both parts 1 and 2, cohorts of 6-12 patients receive escalating doses of ZD 1839 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 6 or 4 of 12 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005806
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Vincent A. Miller, MD||Memorial Sloan Kettering Cancer Center.|