The Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for Extensive Stage Small Cell Lung Cancer (ICE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by University Hospital Southampton NHS Foundation Trust.
Sponsor:
Collaborators:
Cancer Research UK
Institute of Cancer Research, United Kingdom
Bristol-Myers Squibb
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT01331525
First received: April 4, 2011
Last updated: October 16, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Extensive Stage Small Cell Lung Cancer
Biological: Ipilimumab
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation Trust.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 40
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)
Arms Assigned Interventions
Experimental: Single stage non-randomised
There is no randomisation for this study. All patients treated will form the 'intention to treat' population.
Biological: Ipilimumab
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.
Other Names:
  • Yervoy
  • MDX-010
  • BMS-734016

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to give written informed consent.
  • Histological or cytological diagnosis of small cell lung cancer.
  • Adequate baseline laboratory tests.
  • No active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
  • Performance status ECOG 0 or 1.
  • Men and women, 18 years of age and above.

Exclusion Criteria:

  • Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation.
  • Symptomatic CNS metastases.
  • A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 5 years, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
  • Clinically significant autoimmune disease.
  • Any underlying medical, neurological or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs.
  • Administration of any live vaccine for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
  • Previous chemotherapy for small cell lung cancer.
  • A history of prior treatment with immunostimulatory antibodies ipilimumab, prior CD137 agonist or CTLA 4 inhibitor or agonist.
  • Concomitant therapy with any of the following: Interleukin 2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids.
  • Women of childbearing potential (WOCBP), as defined in the protocol and who:

    • Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of their participation in the study and for at least 8 weeks after cessation of study drug, or
    • Have a positive pregnancy test at baseline, or
    • Are pregnant or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331525

Contacts
Contact: Nadia P Cross +44 (0) 2380 795774 N.Cross@soton.ac.uk
Contact: Kelly Cozens +44 (0) 23 8079 8834 kc8@southampton.ac.uk

Locations
United Kingdom
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Contact: Michelle Stokes    +44 (0) 1202 726127      
Principal Investigator: Tom Geldart         
Leeds Teaching Hospitals NHS Foundation Trust 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    h.nicholas@qmul.ac.uk   
Principal Investigator: Peter W Szlosarek         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Vanessa Potter       vanessa.potter@nuh.nhs.uk   
Principal Investigator: Vanessa Potter         
Weston Park Clinical Trials Centre Recruiting
Sheffield, United Kingdom, S10 2SJ
Contact: Alison Redfearn    +44 (0)114 226 5160      
Principal Investigator: Penella Woll         
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         
The Clatterbridge Cancer Centre NHS Foundation Trust Recruiting
Wirral, United Kingdom, CH63 4JY
Contact: Pam Brereton       pam.brereton@clatterbridgecc.nhs.uk   
Principal Investigator: Richard Griffiths         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
Cancer Research UK
Institute of Cancer Research, United Kingdom
Bristol-Myers Squibb
Investigators
Study Chair: Christian H Ottensmeier, MD, PhD University Hospital Southampton NHS Foundation Trust.
Principal Investigator: Matthew Wheater, MD University Hospital Southampton NHS Foundation Trust.
  More Information

No publications provided

Responsible Party: University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier: NCT01331525     History of Changes
Other Study ID Numbers: RHM CAN0739
Study First Received: April 4, 2011
Last Updated: October 16, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospital Southampton NHS Foundation Trust.:
Small cell lung cancer
Chemotherapy
Immunotherapy
CTLA-4
Ipilimumab

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014