Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00856830|
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer Extensive Stage Lung Cancer Chemonaive||Drug: Novel Drug Combination||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single arm, open-label, Phase I - II trial with an initial dose escalation component and an expansion cohort of patients treated at the recommended Phase II dose.|
|Masking:||None (Open Label)|
|Official Title:||Phase I/IIa Study of the Novel Combination of Bendamustine With Irinotecan Followed by Etoposide/Carboplatin in Chemonaive Patients With Extensive Stage Small Cell Lung Cancer|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2016|
Experimental: Novel Drug Combination
This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.
This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
Drug: Novel Drug Combination
This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.
- Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I [ Time Frame: 9 weeks ]The determination of the dose limiting toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3 as follows: grade 4 neutropenia >5 days; grade 3/4 febrile neutropenia; grade 4 thrombocytopenia; or grade >2 non-hematologic toxicities (except for nausea/vomiting, alopecia, or fatigue).
- Number of Patients With Adverse Events - Phase II [ Time Frame: 9 weeks ]The degree of toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3.
- Progression Free Survival [ Time Frame: 7 months ]Using the Response Evaluation Criteria in Solid Tumors (RECIST 2000), progression is defined as 20% or greater increase from the baseline tumor parameters or new lesions.
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): NCT00856830
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294 - 0104|
|United States, Georgia|
|Georgia Cancer Specialists|
|Marietta, Georgia, United States, 30060|
|Principal Investigator:||Francisco Robert, M.D.||University of Alabama at Birmingham|