Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006929
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2000-12-06
Brief Title:
Suramin Paclitaxel and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Carboplatin Paclitaxel Suramin Chemotherapy in Non-Small Cell Lung Cancer NSCLC
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:
Phase II trial to study the effectiveness of combining suramin paclitaxel and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer 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
Detailed Description:
PRIMARY OBJECTIVES
I Determine the minimum effective dose of suramin that will reduce resistance to chemotherapy with paclitaxel and carboplatin in patients with stage IIIB or IV non-small cell lung cancer phase I Phase I closed to accrual 12902
II Evaluate pharmacokinetic interactions of this drug combination in these patients phase I Phase I closed to accrual 12902
III Determine the objective response rate in patients treated with this regimen phase II chemotherapy-naive patients closed to accrual 9103
IV Determine the time to tumor progression progression-free rate at 6 months and 1-year survival of patients treated with this regimen phase II chemotherapy-naive patients closed to accrual 9103
OUTLINE Patients in phase II are stratified according to prior treatment chemotherapy naive closed to accrual 9103 vs chemotherapy refractory Phase I phase I closed to accrual 12902
Patients receive suramin IV over 30 minutes on days 1 and 2 Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of suramin until the target dose is determined The target dose is defined as the dose at which at least 5 of 6 patients achieve optimal plasma concentrations of suramin and no more than 1 of 6 patients exceed optimal level Doses of paclitaxel are adjusted until the maximum tolerated dose in combination with suramin and paclitaxel is determined
Phase II chemotherapy-naive patients closed to accrual 9103 Patients receive the target dose of suramin IV over 30 minutes on days 1 and 2 Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3-6 weeks
PROJECTED ACCRUAL Approximately 82 patients 18 for phase I phase I closed to accrual 12902 and 64 for phase II chemotherapy-naive patients closed to accrual 9103 will be accrued for this study
I Determine the minimum effective dose of suramin that will reduce resistance to chemotherapy with paclitaxel and carboplatin in patients with stage IIIB or IV non-small cell lung cancer phase I Phase I closed to accrual 12902
II Evaluate pharmacokinetic interactions of this drug combination in these patients phase I Phase I closed to accrual 12902
III Determine the objective response rate in patients treated with this regimen phase II chemotherapy-naive patients closed to accrual 9103
IV Determine the time to tumor progression progression-free rate at 6 months and 1-year survival of patients treated with this regimen phase II chemotherapy-naive patients closed to accrual 9103
OUTLINE Patients in phase II are stratified according to prior treatment chemotherapy naive closed to accrual 9103 vs chemotherapy refractory Phase I phase I closed to accrual 12902
Patients receive suramin IV over 30 minutes on days 1 and 2 Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of suramin until the target dose is determined The target dose is defined as the dose at which at least 5 of 6 patients achieve optimal plasma concentrations of suramin and no more than 1 of 6 patients exceed optimal level Doses of paclitaxel are adjusted until the maximum tolerated dose in combination with suramin and paclitaxel is determined
Phase II chemotherapy-naive patients closed to accrual 9103 Patients receive the target dose of suramin IV over 30 minutes on days 1 and 2 Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3-6 weeks
PROJECTED ACCRUAL Approximately 82 patients 18 for phase I phase I closed to accrual 12902 and 64 for phase II chemotherapy-naive patients closed to accrual 9103 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 |
|---|---|---|---|
| OSU 0045 | None | None | None |
| OSU-0045 | None | None | None |
| OSU-00HO224 | None | None | None |
| NCI-2250 | None | None | None |
| CDR0000068345 | None | None | None |
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |