Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase I/II Study of Carboplatin / Paclitaxel / Suramin Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)
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.
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 1/29/02).
II. Evaluate pharmacokinetic interactions of this drug combination in these patients (phase
I). (Phase I closed to accrual 1/29/02).
III. Determine the objective response rate in patients treated with this regimen (phase II
[chemotherapy-naive patients closed to accrual 9/1/03]).
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 9/1/03]).
OUTLINE: Patients in phase II are stratified according to prior treatment (chemotherapy
naive [closed to accrual 9/1/03] vs chemotherapy refractory). Phase I (phase I closed to
accrual 1/29/02):
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 9/1/03): 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
1/29/02] and 64 for phase II [chemotherapy-naive patients closed to accrual 9/1/03]) will be
accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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