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ERCC1 Targeted Trial (ET)

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ClinicalTrials.gov Identifier: NCT00801736
Recruitment Status : Terminated (The antibody used did not appear prognostic/predictive based on interim results.)
First Posted : December 3, 2008
Last Update Posted : December 10, 2013
Sponsor:
Collaborators:
Eli Lilly and Company
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE December 2, 2008
First Posted Date  ICMJE December 3, 2008
Last Update Posted Date December 10, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
Overall Survival [ Time Frame: Dec 2014 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
Median survival time
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
Time to progression [ Time Frame: Dec 2014 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
  • Progression-free survival
  • Overall survival
  • Time to disease progression
  • Relationship between smoking and histology and gender and histology
  • Response rate (i.e., complete response, partial response, stable disease, or progressive disease) as assessed by RECIST criteria
  • Relationship between ERCC1 status and treatment
  • Relationship between ERCC1 status and histology
  • Toxicity as assessed by NCI CTCAE v3.0
  • Quality of life as assessed by EORTC-QLQ C30, LC 13, and EuroQol EQ-5D questionnaires at baseline, prior to each course of treatment, at 21-28 days after completion of treatment, and then at 6, 12, 18, and 24 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ERCC1 Targeted Trial
Official Title  ICMJE A Multicentre, Randomised, Phase III Trial of Platinum-based Chemotherapy Versus Non-platinum Chemotherapy, After ERCC1 Stratification, in Patients With Advanced/Metastatic Non-small Cell Lung Cancer
Brief Summary Lung cancer is the leading cause of cancer death in the UK, leading to 34 000 deaths each year (22% of cancer deaths). Non-small cell lung cancer (NSCLC) is the most common histology, accounting for approximately 80% of cases and most present with advanced, stage IIIb or IV disease. The recommended treatment for advanced disease is a doublet platinum-based chemotherapy, although the survival benefits are modest. Even among those fit enough for chemotherapy, the response rate is only 20-40%, and median survival averages 9-10 months with the newer platinum-containing chemotherapy regimen (Schiller et al, 2002; Rudd et al, 2005; Lee et al, 2007). Only 11% of patients went on to survive 2 years when treated with the newer gemcitabine/carboplatin regimen established by the London Lung Cancer Group (Rudd et al, 2005; Lee et al, 2007). New strategies are needed to further improve the prognosis of this disease.
Detailed Description

TRIAL OBJECTIVES

Primary objective

The trial will have two main objectives:

  • To detect an improvement in survival for ERCC1+ve patients treated with a non-platinum chemotherapy compared to platinum-based treatment.
  • To establish non-inferiority or improvement in survival for ERCC1-ve patients treated with a platinum-based chemotherapy compared to non-platinum treatment.

Secondary objectives

  • To examine progression-free survival, response rate and quality of life between the two treatment regimens, according to ERCC1 status.
  • To investigate whether the treatment effect differs according to histology (squamous vs. nonsquamous);gender (males vs. females); performance status
  • To undertake a cost-effectiveness analysis based on all patients, and according to ERCC1 status.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Drug: Cisplatin, Paclitaxel
  • Cisplatin 75mg/m2, Day 1
  • Paclitaxel 175mg/m2, Day 1
Study Arms  ICMJE
  • Experimental: Platinum Arm
    Cisplatin (IMP) / Pemetrexed (IMP)
    Intervention: Drug: Cisplatin, Paclitaxel
  • Experimental: Non Platinum Arm
    Paclitaxel (IMP) / Pemetrexed (IMP)
    Intervention: Drug: Cisplatin, Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 9, 2013)
648
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2008)
1272
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  1. Histological confirmation of non-squamous NSCLC
  2. Have a tissue biopsy available for sending to the central laboratory to determine ERCC1 status
  3. Presentation with stage IIIb (not amenable to curative treatment) or IV disease - staging scans must be no more than 28 days prior to registration. Patients with relapsed NSCLC must not have received prior chemotherapy or biological therapy (previous surgery or radical radiotherapy allowed)
  4. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours
  5. Either sex, at least 18 years of age
  6. ECOG performance status 0-1
  7. Estimated life expectancy of at least 8 weeks
  8. Adequate bone marrow function as evidenced by the following (assessed within 14 days of registration):

    • Absolute neutrophil count (ANC) ≥1.5 × 109/L
    • Platelet count ≥100 × 109/L
    • Haemoglobin ≥9 g/dL
  9. Adequate liver function as evidenced by the following (assessed within 14 days of registration):

    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • Aspartate transaminase (AST) ≤3 × ULN or ≤5 × ULN is acceptable with liver metastases
    • Alanine transaminase (ALT) ≤3 × ULN
  10. Adequate renal function as evidenced by the following (assessed within 14 days of registration):

    - GFR > 60ml/min as measured by creatinine clearance through EDTA. Alternatively, the Cockcroft and Gault formula may be used to estimate GFR, but if < 60 ml/min then EDTA should be performed.

  11. Previous palliative radiotherapy to non-target metastatic lesions is allowed for pain relief prior to starting chemotherapy
  12. Patients with stable brain metastases will be allowed to enrol. Stable brain metastases being defined as no progression of brain metastases 28 days after treatment as documented by a CT scan/MRI of the brain. Patients with incidentally discovered asymptomatic brain metastases may be enrolled and treated with trial chemotherapy without prior brain irradiation if deemed feasible by the treating physician
  13. Signed informed consent form
  14. Use of effective contraception during, and for 6 months after trial treatment by patients of reproductive potential and partners of reproductive potential. Patients who receive aprepitant (anti-emetic) must be willing to use an alternative or back-up method to hormonal contraceptives as aprepitant may reduce their efficacy. Female patients with childbearing potential must have a negative serum pregnancy test prior to registration.

EXCLUSION CRITERIA

  1. Cytologically or clinically diagnosed NSCLC
  2. Evidence of significant medical condition or laboratory finding which, in the opinion of the treating physician or chief investigator, makes it undesirable for the patient to participate in the trial
  3. Presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy
  4. Presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to trial entry
  5. Yellow fever vaccination received within the 30 days previous to study entry
  6. Unable to interrupt aspirin or other NSAIDs (for pemetrexed arms of the trial)
  7. Unable or unwilling to take vitamin B12 and folic acid (for pemetrexed arms of the trial)
  8. A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
  9. Pregnant or lactating women
  10. Inability to comply with protocol or trial procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00801736
Other Study ID Numbers  ICMJE ISRCTN02370070
CRUK-UCL-ET
EUDRACT-2007-007639-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University College, London
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University College, London
Original Study Sponsor  ICMJE Cancer Research UK
Collaborators  ICMJE
  • Eli Lilly and Company
  • Cancer Research UK
Investigators  ICMJE
Principal Investigator: Siow M. Lee, MD, PhD, FRCP Cancer Research UK
PRS Account University College, London
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP