Irinotecan
Drug50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
Other names: Camptosar
NCT Number: NCT00193375
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Upon determination of eligibility, all patients will be receive:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To be included in this study, you must meet the following criteria:
Exclusion criteria
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4
Other names: Camptosar
AUC 5
Other names: Paraplatin
10mg/kg IV every 2 weeks for 10 doses starting week 16
Other names: Avastin
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.
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.
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.
SCRI Development Innovations, LLC
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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