7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00098956|
Recruitment Status : Completed
First Posted : December 9, 2004
Results First Posted : September 9, 2015
Last Update Posted : September 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer||Drug: topotecan hydrochloride Drug: 7-hydroxystaurosporine||Phase 2|
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).
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 (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of UCN-01 in Combination With Topotecan in Patients With SCLC Who Relapsed or Progressed >= 3 Months After Completing First-Line Platinum-Based Chemotherapy|
|Study Start Date :||January 2005|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2010|
Experimental: Treatment (topotecan hydrochloride, UCN-01)
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 CR or PR receive 2 additional courses beyond CR or PR.
Drug: topotecan hydrochloride
Other Names:Drug: 7-hydroxystaurosporine
Other Name: UCN-01
- Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria [ Time Frame: Up to 5 years ]
- Stable Disease Rate Evaluated Using RECIST Criteria [ 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098956
|Princess Margaret Hospital Phase 2 Consortium|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Glennwood Goss||Princess Margaret Hospital Phase 2 Consortium|