The Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for Extensive Stage Small Cell Lung Cancer (ICE)
This trial will investigate the addition of an antibody (Ipilimumab) to conventional Carboplatin and Etoposide chemotherapy in extensive stage small cell lung cancer.
The primary objective is to establish the progression free survival at 1 year.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of the Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for the First Line Treatment of Extensive Stage Small Cell Lung Cancer (ICE)|
- To establish the progression free survival at 1 year in patients with extensive stage small cell lung cancer treated with ipilimumab, carboplatin and etoposide. [ Time Frame: At 1 year from entering trial ] [ Designated as safety issue: No ]
- Assess tumour response and toxicity of ICE combination. Response measured by RECIST and immune related response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing. [ Time Frame: Throughout clinical trial participation (maximum 6 21 day cycles) plus 100 day follow up from last treatment. ] [ Designated as safety issue: Yes ]
Response: Assessed via Chest X-ray and CT of chest, abdomen and pelvis at weeks 6, 12, 18, 24, 30, 36, 42, 48, 52 and then 12 weekly until progression.
Toxicity: targeted physical, adverse event assessment, assessment of signs and symptoms, quality of life assessment, full blood count plus ALT/ASP, ALP, Billi, Ca, Alb, LDH, Creatinine, urea and electrolytes investigation. Serious adverse events will be reported within 24 hours of first knowledge of the event.
|Study Start Date:||June 2011|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Single stage non-randomised
Patients will receive Carboplatin and Etoposide. Both Chemotherapy drugs will be delivered as a 21 day cycle (q21) with up to a maximum of 6 cycles delivered according to response unless progressive disease (RECIST Version 1.0) and or excessive toxicity.
Ipilimumab will be administered at a dose of 10mg/kg IV on day 1 of cycles 3-6 of Chemotherapy.
In the absence of immune related progression of disease or unacceptable toxicity, subsequent maintenance doses of Ipilimumab will be delivered every 12 weeks starting at week 30 at a dose of 10 mg/kg until unacceptable toxicity or immune related disease progression
This trial will investigate the addition of the anti-CTLA4 antibody ipilimumab to conventional carboplatin and etoposide chemotherapy in extensive stage small cell lung cancer.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01331525
|Royal Bournemouth Hospital|
|Bournemouth, United Kingdom, BH7 7DW|
|Leeds Teaching Hospitals NHS Foundation Trust|
|Leeds, United Kingdom, LS9 7TF|
|Barts and The London NHS Trust|
|London, United Kingdom, EC1M 6BQ|
|Nottingham University Hospitals NHS Trust|
|Nottingham, United Kingdom, NG5 1PB|
|Weston Park Clinical Trials Centre|
|Sheffield, United Kingdom, S10 2SJ|
|Southampton University Hospitals NHS Trust|
|Southampton, United Kingdom, SO16 6YD|
|The Clatterbridge Cancer Centre NHS Foundation Trust|
|Wirral, United Kingdom, CH63 4JY|
|Study Chair:||Christian H Ottensmeier, MD, PhD||University Hospital Southampton NHS Foundation Trust.|
|Principal Investigator:||Matthew Wheater, MD||University Hospital Southampton NHS Foundation Trust.|