Topotecan Hydrochloride and Doxorubicin Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Recurrent Small Cell Lung Carcinoma
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Drug: Topotecan Hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Weekly Doxorubicin and Oral Topotecan for Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)|
- Maximum tolerated dose defined as the next lowest dose level below where greater than or equal to 2/3 or 3/6 patients experience dose limiting toxicities in cohorts of 5 different doses by National Cancer Institute Common Toxicity Criteria version 3.0 [ Time Frame: Up to 6 weeks (after 2 courses) ] [ Designated as safety issue: Yes ]The actual rates of dose limiting toxicities per dose cohort will be presented when applicable.
- Changes in quality of life levels [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]Measured by standard instruments and compared when possible between patients who responded versus nonresponders.
- Changes in topoisomerase I and II levels in peripheral blood mononuclear cells [ Time Frame: Baseline to up to week 16 ] [ Designated as safety issue: No ]The changes over time will be described and correlated with hematological toxicity and efficacy. Mean change and standard deviation over time will be computed and when possible change in topoisomerase levels over time will be compared between patients developing grade 4 hematological toxicities versus others (no toxicity or grades 1-3) or between patients developing grades 3-4 non-hematological toxicities versus others (no toxicity or grades 1-2) or between patients who responded (complete response, partial response, stable disease) versus no response or progressed using non-parametric tests.
- Overall response rate [ Time Frame: Up to 15 weeks (after 5 courses) ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (doxorubicin hydrochloride, topotecan hydrochloride)
Patients receive doxorubicin hydrochloride IV over 3-5 minutes on day 6 of course 1 and on days 6, 13, and 20 of courses 2-5. Patients also receive topotecan hydrochloride PO on days 1-5. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Drug: Doxorubicin Hydrochloride
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentDrug: Topotecan Hydrochloride
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 combination of oral topotecan (topotecan hydrochloride) when given with weekly doxorubicin (doxorubicin hydrochloride) in patients with SCLC.
II. Determine the dose limiting toxicity of oral topotecan when given with weekly doxorubicin in patients with SCLC.
I. Estimate topoisomerase I and II levels in peripheral blood mononuclear cells and correlate with presence or absence of grades 3 and 4 hematological toxicity.
II. Estimate topoisomerase I and II levels in peripheral blood mononuclear cells and correlate with efficacy.
OUTLINE: This is a dose-escalation study of topotecan hydrochloride.
Patients receive doxorubicin hydrochloride intravenously (IV) over 3-5 minutes on day 6 of course 1 and on days 6, 13, and 20 of courses 2-5. Patients also receive topotecan hydrochloride orally (PO) on days 1-5. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856037
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Apar K. Ganti 402-559-6210 email@example.com|
|Principal Investigator: Apar K. Ganti|
|Principal Investigator:||Apar Ganti||University of Nebraska|