Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005806
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1768 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067792 | REGISTRY | None | None |
| ZENECA-1839IL0020 | None | None | None |