Etirinotecan Pegol (NKTR 102) in Treating Patients With Relapsed Small Cell Lung Cancer
This phase II trial studies how well etirinotecan pegol (NKTR 102) works in treating patients with relapsed small cell lung cancer. Etirinotecan pegol (NKTR 102) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Recurrent Small Cell Lung Cancer
Drug: etirinotecan pegol (NKTR 102)
Other: pharmacogenomic studies
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Single Agent Topoisomerase-I Inhibitor Polymer Conjugate, Etirinotecan Pegol (NKTR-102), in Patients With Relapsed Small Cell Lung Cancer|
- Proportion of patients who are progression-free [ Time Frame: Time from registration to the date of first documented disease progression or death, assessed at 18 weeks ] [ Designated as safety issue: No ]The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier. Probability of PFS at 18 weeks and 24 weeks will be estimated.
- Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]The distribution of survival time will be estimated in each group using the method of Kaplan-Meier. Probability of survival at 3, 6, and 9 months will be estimated.
- Objective tumor response measured with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]Objective tumor response will be tabulated overall (and by dose level if appropriate).
- Best response, defined as best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since treatment started), measured by RECIST 1.1 [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in the cohorts (overall and by tumor group).
- Incidence of hematologic and non-hematologic toxicity per NCI Common Toxicity Criteria (CTC) [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
- Number and severity of adverse events, assessed using NCI CTCAE v 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]The number and severity of all adverse events (overall, by regimen, and by dose level if appropriate) will be tabulated and summarized. The grade 3+ adverse events will also be described and summarized in a similar fashion.
|Study Start Date:||August 2013|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment etirinotecan pegol (NKTR 102)
Patients receive etirinotecan pegol (NKTR 102) IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Drug: etirinotecan pegol (NKTR 102)
Other Names:Other: pharmacogenomic studies
Other Name: Pharmacogenomic StudyOther: laboratory biomarker analysis
I. To evaluate the 18-week progression free survival (PFS) rate of relapse small cell lung cancer (SCLC) patients treated with etirinotecan pegol (NKTR-102)
(SECONDARY OBJECTIVES:I. To evaluate the objective response rate. II. To evaluate the duration of response. III. To evaluate the overall survival. IV. To evaluate the toxicity of etirinotecan pegol(NKTR-102) in this patient population.
I. To explore the correlation between UDP glucuronosyltransferase 1 family, polypeptide A cluster (UGTIA1) polymorphisms and etirinotecan pegol (NKTR-102) toxicities.
Patients receive etirinotecan pegol (NKTR 102) intravenously (IV) over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01876446
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org|
|Principal Investigator: Alex A. Adjei|
|Rochester General Hospital||Recruiting|
|Rochester, New York, United States, 14621|
|Contact: Peter Bushunow, MD 585-922-4020|
|Principal Investigator: Peter Bushunow, MD|
|Principal Investigator:||Alex Adjei||Roswell Park Cancer Institute|