Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious. To date there has been no agreement regarding the optimal combination of these agents. Based on the trials described in the protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer|
- Patient Response [ Time Frame: 1.66 months (average duration, on treatment date to best response date) ] [ Designated as safety issue: No ]
Patient response to treatment:
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
- Number of Patients With Adverse Events [ Time Frame: date off treatment or progression of disease, up to 18 weeks ] [ Designated as safety issue: Yes ]Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event
- Time to Progression [ Time Frame: 9.9 months (on study date to progression) ] [ Designated as safety issue: No ]Time to progression in months
- Overall Survival [ Time Frame: On study date to death ] [ Designated as safety issue: No ]
|Study Start Date:||December 2003|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Therapeutic Intervention
Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded or is stable, the patient will continue to be followed for efficacy (i.e. until progressive disease)at 8 week intervals. Following the diagnosis of progressive disease, patients will be followed every two months for survival.
Carboplatin dosage calculation to be given on day 1, every 21 days:
Carboplatin (mg) = (AUC of 5) x (GFR + 25)
*up to 6 cycles at physician's discretion
Other Name: ParaplatinDrug: irinotecan hydrochloride
50 mg/m2 IV on days 1 and 8 every 21 days
Should be infused IV over 30- 90 minutes.
- To examine the anti-tumor efficacy of the combination of Irinotecan (CPT-11) and Carboplatin as first-line therapy as assessed by response rate in patients with chemo-naïve extensive stage small cell lung cancer.
- Determine the safety, tolerability, and feasibility of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open-label study.
Patients receive irinotecan IV over 30-90 minutes on days 1 and 8 and carboplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469898
|United States, Kentucky|
|Owensboro Medical Health System|
|Owensboro, Kentucky, United States, 42303|
|United States, Tennessee|
|Memorial Health Care System|
|Chattanooga, Tennessee, United States, 37404|
|West Tennessee Cancer Center at Jackson-Madison County General Hospital|
|Jackson, Tennessee, United States, 38301|
|Tennessee Cancer Specialists|
|Knoxville, Tennessee, United States, 37901|
|MBCCOP - Meharry Medical College - Nashville|
|Nashville, Tennessee, United States, 37208|
|St. Thomas Health Services|
|Nashville, Tennessee, United States, 37205|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, Canada, V52 4|
|Principal Investigator:||Leora Horn, MD||Vanderbilt-Ingram Cancer Center|