Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00193375|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Irinotecan Drug: Carboplatin Drug: Bevacizumab Radiation: Radiation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||May 2008|
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: Camptosar
Other Name: Paraplatin
10mg/kg IV every 2 weeks for 10 doses starting week 16
Other Name: Avastin
- 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 ]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: 24 months ]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 ]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.
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): NCT00193375
|Principal Investigator:||John D. Hainsworth, MD||SCRI Development Innovations, LLC|