Phase I/II Study of Oral Topotecan and Intravenous Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (Phases I and II) and Other Advanced Solid Tumors (Phase I Only)
OBJECTIVES: Phase I: I. Determine the maximum tolerated dose (MTD) of oral topotecan
combined with a fixed dose of paclitaxel in patients with advanced non-small lung cancer
(NSCLC) and other advanced solid tumors. II. Determine the response rate of NSCLC patients
treated at the MTD of oral topotecan combined with intravenous paclitaxel. III. Determine
the dose limiting toxicities of this drug combination in this patient population. Phase II:
IV. Determine the toxicities of this regimen at its MTD in patients with NSCLC. V. Determine
time to response, response duration, survival, time to progression, and rate of stable
disease of patients with NSCLC treated with this regimen at the MTD. VI. Assess changes in
well-being of patients with NSCLC treated with this regimen at the MTD.
OUTLINE: This is a dose escalation study of topotecan. Patients receive oral topotecan on
days 1-5 and paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the
absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive
escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
limiting toxicities. Once the MTD is determined, additional patients with non-small cell
lung cancer are accrued to receive treatment with topotecan and paclitaxel at the
recommended phase II dose. Quality of life is assessed in the phase II portion of the study
at baseline, before each treatment course, and at the end of the study. Patients are
followed at 3 weeks.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I dose escalation
portion of this study. A total of 14-40 additional non-small cell lung cancer patients will
be accrued to the phase II portion of this study.
Interventional
Primary Purpose: Treatment
Robert A. Figlin, MD, FACP
Study Chair
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000067543
NCT00004979
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