- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00801736
ERCC1 Targeted Trial (ET)
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
Study Overview
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- University College London Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
- Histological confirmation of non-squamous NSCLC
- Have a tissue biopsy available for sending to the central laboratory to determine ERCC1 status
- 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)
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours
- Either sex, at least 18 years of age
- ECOG performance status 0-1
- Estimated life expectancy of at least 8 weeks
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
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
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.
- Previous palliative radiotherapy to non-target metastatic lesions is allowed for pain relief prior to starting chemotherapy
- 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
- Signed informed consent form
- 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
- Cytologically or clinically diagnosed NSCLC
- 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
- Presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy
- 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
- Yellow fever vaccination received within the 30 days previous to study entry
- Unable to interrupt aspirin or other NSAIDs (for pemetrexed arms of the trial)
- Unable or unwilling to take vitamin B12 and folic acid (for pemetrexed arms of the trial)
- 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
- Pregnant or lactating women
- Inability to comply with protocol or trial procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Platinum Arm
Cisplatin (IMP) / Pemetrexed (IMP)
|
|
Experimental: Non Platinum Arm
Paclitaxel (IMP) / Pemetrexed (IMP)
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: Dec 2014
|
Dec 2014
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to progression
Time Frame: Dec 2014
|
Dec 2014
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Siow M. Lee, MD, PhD, FRCP, Cancer Research UK
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- ISRCTN02370070
- CRUK-UCL-ET
- EUDRACT-2007-007639-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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