A trial to see if a body protein called ERCC1 affects how people with advanced non small cell lung cancer respond to different types of chemotherapy

• Conditions: on-small cell lung cancer; MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-007639-17-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-16
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1272

Inclusion Criteria

a) Histologically confirmed NSCLC
b) Have a tissue biopsy available for sending to the central laboratory to determine ERCC1 status
c) 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)
d) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST)
e) Either sex, at least 18 years of age
f) ECOG performance status 0-1
g) Estimated life expectancy of at least 8 weeks
h) Adequate bone marrow function as evidenced by the following (assessed within 14 days of starting treatmentregistration):
- Absolute neutrophil count (ANC) =1.5 × 10^9/L
- Platelet count =100 × 10^9/L
- Haemoglobin =9 g/dL
i) 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, OR
- Alanine transaminase (ALT) =3 × ULN or =5 × ULN is acceptable with liver metastases
j) Adequate renal function as evidenced by the following (assessed within 14 days of registration):
- GFR > 60ml/min as measured by EDTA. The Cockcroft and Gault formula (see appendix 5) may be used to estimate GFR, but if < 60 ml/min then EDTA should be performed.
k) Previous palliative radiotherapy to non-target metastatic lesions is allowed (not in the 28 days prior to registration)
l) 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
m) Signed informed consent form
n) 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 randomisationregistration

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1272
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1272

Exclusion Criteria

a) Cytologically or clinically diagnosed NSCLC
b) 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, e.g congestive heart failure; myocardial infarction within 6 months; significant neurological or psychiatric disorders that would impact trial participation; infection requiring I.V. antibiotics; tuberculosis with ongoing therapy at trial entry; superior vena cava syndrome, except if controlled with radiation; active peptic ulcer disease; uncontrolled diabetes mellitus ; any contraindication to high dose corticosteroid therapy such as herpes simplex, herpes zoster, hepatitis, or other disease
c) Presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy
d) 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
e) Yellow fever vaccination received within the 30 days previous to study entry
f) Unable to interrupt aspirin or other NSAIDS (for pemetrexed arms of the trial)
g) Unable or unwilling to take vitamin B12 and folic acid (for pemetrexed arms of the trial)
h) 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
i) Pregnant or lactating women
j) Inability to comply with protocol or trial procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified