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Lung CancerPhase 3ETNCT00801736

ERCC1 Targeted Trial

A Phase 3 study testing Cisplatin, Paclitaxel in people with Lung Cancer, run by University College, London at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lung Cancer
What is being tested?
Cisplatin, Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
648 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2009to Jul 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University College London Hospitals

    London

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the 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.
Conditions
Lung Cancer
Being tested
Cisplatin, Paclitaxel
Keywords
Recurrent non-small cell lung cancer, Stage IIIB non-small cell lung cancer, Stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cisplatin, PaclitaxelDrug

    • Cisplatin 75mg/m2, Day 1
    • Paclitaxel 175mg/m2, Day 1
Study groups in NCT00801736
Study groupRoleWhat they receive
Platinum ArmExperimentalCisplatin (IMP) / Pemetrexed (IMP)
Receives: Drug: Cisplatin, Paclitaxel
Non Platinum ArmExperimentalPaclitaxel (IMP) / Pemetrexed (IMP)
Receives: Drug: Cisplatin, Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: Dec 2014

Secondary outcomes (1)

  1. Time to progression

    Measured: Dec 2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2008 (estimated)
  2. Study startOct 2009
  3. Primary completionJul 2013

Why it stopped: The antibody used did not appear prognostic/predictive based on interim results.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801736
Sponsor's protocol ID
ISRCTN02370070
Other IDs
CRUK-UCL-ET, EUDRACT-2007-007639-17
Acronym
ET
Status last verified
Dec 2012
First submitted
2 Dec 2008
Last updated
10 Dec 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Paclitaxel in people with Lung Cancer, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The antibody used did not appear prognostic/predictive based on interim results.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Dec 2014). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00801736.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.

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