A Randomized Phase II Study of IV Topotecan Versus CRLX101 in the Second Line Treatment of Recurrent Small Cell Lung Cancer
PRIMARY OBJECTIVES:
I. To evaluate the effect of second-line treatment with CRLX101 (cyclodextrin-based
polymer-camptothecin CRLX101) compared to intravenous (IV) topotecan hydrochloride
(topotecan) on progression free survival (PFS) of patients with extensive-stage small cell
lung cancer (ES-SCLC) sensitive to first-line platinum-based chemotherapy.
II. To evaluate the effect of second-line treatment with CRLX101 on the three-month PFS rate
of patients with ES-SCLC resistant to first-line platinum-based chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate the response rate of second-line treatment with CRLX101 in patients with
ES-SCLC who are sensitive or resistant to first-line platinum-based chemotherapy.
II. To evaluate the effect of second-line treatment with CRLX101 compared to IV topotecan on
overall survival (OS) of patients with ES-SCLC sensitive to first-line platinum-based
chemotherapy.
III. To assess the overall survival of second-line treatment with CRLX101 in patients with
ES-SCLC resistant to first-line platinum-based chemotherapy.
IV. To assess the toxicity of second-line CRLX101 in patients sensitive or resistant to
first-line platinum-based chemotherapy.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A (Sensitive Relapse): Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive topotecan hydrochloride intravenously (IV) over 30 minutes on days
1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.
ARM B: Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes
on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
COHORT B (Resistant Relapse): Patients receive cyclodextrin-based polymer-camptothecin
CRLX101 as in Arm B Cohort A. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks and then every 3
months thereafter.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS
Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test. Ninety-percent confidence intervals for median PFS time in each arm will be calculated using the method of Brookmeyer and Crowley.
From randomization to time of progression or death from any cause, assessed up to 2 years
No
Ravi Salgia
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
12-1726
NCT01803269
January 2013
Name | Location |
---|---|
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |