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|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Single stage non-randomised
There is no randomisation for this study. All patients treated will form the 'intention to treat' population.
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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|Contact: Nadia P Cross||+44 (0) 2380 795774||N.Cross@soton.ac.uk|
|Contact: Kelly Cozens||+44 (0) 23 8079 email@example.com|
|Royal Bournemouth Hospital||Not yet recruiting|
|Bournemouth, United Kingdom, BH7 7DW|
|Contact: Michelle Stokes +44 (0) 1202 726127|
|Principal Investigator: Tom Geldart|
|Addenbrooke's Hospital||Not yet recruiting|
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Vicky Kingshott +44 (0) 1223 216083|
|Principal Investigator: Tim Eisen|
|Leeds Teaching Hospitals NHS Foundation Trust||Not yet recruiting|
|Leeds, United Kingdom, LS9 7TF|
|Contact: Jennifer Boards +44 (0) 113 20 67967|
|Principal Investigator: Clive Mulatero|
|Barts and The London NHS Trust||Not yet recruiting|
|London, United Kingdom, EC1M 6BQ|
|Contact: Hanna Nicholas +44 (0)20 7882 8490 firstname.lastname@example.org|
|Principal Investigator: Peter W Szlosarek|
|Weston Park Clinical Trials Centre||Not yet recruiting|
|Sheffield, United Kingdom, S10 2SJ|
|Contact: Alison Redfearn +44 (0)114 226 5160|
|Principal Investigator: Sarah Danson|
|Southampton University Hospitals NHS Trust||Recruiting|
|Southampton, United Kingdom, SO16 6YD|
|Contact: Nadia Cross +44 (0) 2380 795774|
|Principal Investigator: Christian H Ottensmeier, MD, PhD|
|Sub-Investigator: Matthew Wheater|
|Study Chair:||Christian H Ottensmeier, MD, PhD||University Hospital Southampton NHS Foundation Trust.|
|Principal Investigator:||Matthew Wheater, MD||University Hospital Southampton NHS Foundation Trust.|