Topotecan and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Did Not Respond to Previous Systemic Chemotherapy
RATIONALE: 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. Monoclonal antibodies, such as Avastin (bevacizumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving topotecan together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving topotecan together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer that did not respond to previous systemic chemotherapy.
Drug: topotecan hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Study of Weekly Topotecan in Combination With Avastin™ in Patients With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Prior Systemic Chemotherapy|
- Median Time to Disease Progression [ Time Frame: From Day 1 Until First Documented Disease Progression or Date of Death (Whichever Occurred First) ] [ Designated as safety issue: No ]Assessed by Response Evaluation Criteria In Solid Tumor (RECIST criteria). Progression is defined as a measureable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions since baseline.
- Number of Tumor Responders [ Time Frame: From Day 1 Until Disease Progression or Date of Death (Whichever Occurred First), Up to 1 Year ] [ Designated as safety issue: No ]Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
- Median Time to Response [ Time Frame: From Day 1 Until Tumor Response ] [ Designated as safety issue: No ]Defined as the time from the start of treatment until first documented evidence of at least a partial tumor response.
- Median Duration of Response [ Time Frame: Day of 1st Response Until Disease Progression of Death/Last Contact ] [ Designated as safety issue: No ]Defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to progressive disease. For subjects who do not progress or die, duration of response will be censored at the time of last contact.
- Median Overall Survival [ Time Frame: From Day 1 Until Death Occurred ] [ Designated as safety issue: No ]Defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.
|Study Start Date:||September 2006|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Patients Treated With Topotecan and Avastin in NSCLC
Weekly topotecan hydrochloride and bi-weekly Avastin (bevacizumab) in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
Will be given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration until disease progression or for another reason.
Other Name: AvastinDrug: topotecan hydrochloride
Topotecan 4 mg/m^2 intravenously (IV) will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22. Treatment will be repeated every 28 days until disease progression or for another reason.
Other Name: Hycamtin(TM)
- Determine the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer treated with topotecan hydrochloride and bevacizumab who have failed prior systemic chemotherapy.
- Determine the objective response rates in patients treated with this regimen.
- Measure time-to-event efficacy variables, including time to objective tumor response (for responding patients), duration of response (for responding patients), time to treatment failure, and overall survival.
- Characterize the quantitative and qualitative toxicities of this regimen in these patients.
OUTLINE: Patients receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 and Avastin (bevacizumab) IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 6 months from registration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365547
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Park Nicollet Cancer Center|
|St. Louis Park, Minnesota, United States, 55416|
|Principal Investigator:||Arkadiusz Dudek, MD||Masonic Cancer Center, University of Minnesota|