A Phase I Study of Weekly Doxorubicin and Oral Topotecan for Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)
I. Evaluate the safety and efficacy, in terms of clinical disease benefit (complete or
partial response and stable disease with stable or improved quality of life scores), of
treatment with doxorubicin hydrochloride and topotecan hydrochloride in patients with
relapsed or refractory small cell lung cancer.
II. Determine the dose-limiting toxicity of topotecan hydrochloride administered in
combination with doxorubicin hydrochloride in these patients.
I. Estimate topoisomerase I and II levels in peripheral blood mononuclear cells and
correlate them with the presence or absence of grades 3 and 4 hematological toxicity.
II. Estimate topoisomerase I and II levels in peripheral blood mononuclear cells and
correlate them with efficacy.
OUTLINE: This is a dose-escalation study of topotecan hydrochloride.
Patients receive doxorubicin hydrochloride IV weekly beginning on day 6 in weeks 1-15.
Patients also receive oral topotecan hydrochloride on days 1-5 in weeks 1, 4, 7, 10, and 13
in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline, and at weeks 7 and 16 to measure topoisomerase I
and II levels. Patients also complete the FACT-L quality of life questionnaire at baseline,
and at weeks 7 and 16.
After completion of study treatment, patients are followed every 2 months
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and efficacy of this regimen as assessed by the maximum tolerated dose (MTD) of the next lowest dose level below where greater than or equal to 2/3 or 3/6 patients experience dose limiting toxicities (DLT) in cohorts of 5 different doses
After 2 cycles
University of Nebraska
United States: Institutional Review Board
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|