This phase II trial is studying how well giving UCN-01 together with topotecan works in treating patients with small cell lung cancer that relapsed or progressed after previous chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. UCN-01 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also increase the effectiveness of topotecan by making tumor cells more sensitive to the drug. Giving UCN-01 together with topotecan may kill more tumor cells.
PRIMARY OBJECTIVES: I. To determine the anti tumour activity of UCN-01 in combination with topotecan in patients with SCLC who relapsed or progressed \>= 3 months after completing first-line platinum-based chemotherapy (patient with sensitive disease) using objective response rates (complete and partial). SECONDARY OBJECTIVES: I. To determine the anti tumour activity of UCN-01 in combination with topotecan with regards to stable disease rate, median and overall survival rates as well as to determine the safety and tolerability of this combination. OUTLINE: This is a multicenter study. Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients are followed for survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Given IV
Given IV
Princess Margaret Hospital Phase 2 Consortium
Toronto, Ontario, Canada
Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time frame: Up to 5 years
Stable Disease Rate Evaluated Using RECIST Criteria
Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time frame: Up to 5 years
Duration of Responses
Time frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
Progression-free Survival
Time frame: From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years
Overall Survival
Time frame: From the date of enrollment to death or last contact, assessed up to 5 years
Adverse Events, Graded Using the CTCAE Version 3.0
Time frame: Up to 5 years
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