Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Concurrent Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab (Avastin) in the Treatment of Patients With Limited Stage Small Cell Lung Cancer|
- Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.
- 2-Year Progression-free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.
- Overall Response Rate [ Time Frame: 18 month ] [ Designated as safety issue: No ]Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
|Study Start Date:||August 2003|
|Study Completion Date:||May 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
Other Name: CamptosarDrug: Carboplatin
Other Name: ParaplatinDrug: Bevacizumab
10mg/kg IV every 2 weeks for 10 doses starting week 16
Other Name: AvastinRadiation: Radiation
Upon determination of eligibility, all patients will be receive:
- Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab
Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193375
|Principal Investigator:||John D. Hainsworth, MD||SCRI Development Innovations, LLC|