7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||June 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|