Clinical trial NCT01803269
Conditions: Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer
Sponsor: University of Chicago
Start date: 2013-01-16; Completion date: 2016-03-30
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well giving topotecan hydrochloride or cyclodextrin-based polymer-camptothecin CRLX101 works in treating patients with recurrent small cell lung cancer. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclodextrin-based polymer-camptothecin CRLX101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether topotecan hydrochloride is more effective than cyclodextrin-based polymer-camptothecin CRLX101 in treating patients with lung cancer.

Detailed description:
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.

Arms: arm 1: Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive cyclodextrin-based polymer-camptothecin CRLX10 cyclodextr1 IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: topotecan hydrochloride intervention 2: cyclodextrin-based polymer-camptothecin CRLX101
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents: