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ISRCTN
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ISRCTN27242710
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ClinicalTrials.gov identifier
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Public title
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A phase II trial of docetaxel in the treatment of elderly patients (aged 70 or over) with non-small cell lung cancer
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Scientific title
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Acronym
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ELTAX
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Serial number at source
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NSCLC-DOCET_L_02602
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Study hypothesis
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To assess the efficacy of docetaxel (60 mg/m^2, on day one of every 21-day cycle [d1, q21]) as first line chemotherapy in elderly patients with advanced non-small cell lung cancer (NSCLC).
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Ethics approval
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In progress through NRES, pending as of 14/01/2008.
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Study design
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Simon 2 stage MiniMax: this is a single arm (non-randomised) phase II trial with 2 stages
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Advanced stage non small cell lung cancer
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Participants - inclusion criteria
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1. Aged greater than or equal to 70 on the day of first treatment
2. Histologically or cytologically confirmed NSCLC
3. Any stage not suitable for surgery or radical radiotherapy
4. Radiologically evaluable disease (by Response Evaluation Criteria In Solid Tumours [RECIST] criteria) of at least one measurable lesion on chest X-ray (CXR) or computed tomography (CT)
5. Performance status World Health Organization (WHO) of 0, 1 or 2
6. Life expectancy greater than 12 weeks
7. Adequate haematological and biochemical function
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Participants - exclusion criteria
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1. Prior chemotherapy (previous surgery and palliative radiotherapy are allowed)
2. Uncontrolled non-cancer systemic disease
3. Significant clinical or laboratory abnormalities
4. Concomitant or previous malignancy likely to interfere with treatment outcome
5. WHO performance status of worse than 2
6. Inadequate renal function
7. Inadequate bone marrow function
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Anticipated start date
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01/01/2008
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Anticipated end date
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01/01/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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55
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Interventions
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This is a single arm (non-randomised) phase II trial with 2 stages. The first stage will involve recruiting 31 patients. If there is evidence of activity then the trial will complete recruitment of a further 24 patients.
Patients will be treated with docetaxel 60 mg/m^2 intravenously (iv) once every 3 weeks for 4 - 6 cycles. Patients will be followed up until death.
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Primary outcome measure(s)
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Response rate, measured by RECIST criteria once all patients have completed protocol defined therapy.
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Secondary outcome measure(s)
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1. Progression free survival, measured using the Kaplin Meier method
2. Overall survival, measured using the Kaplin Meier method
3. Survival in patients who received less than or equal to 2, greater than 2 but no more than 4 versus more than four 4 cycles of chemotherapy, measured using the Kaplin Meier method
4. Toxicity
5. Quality of life, measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ-C30 and QLQ-LC13). Scoring will be performed using the EORTC QLQ-C30 scoring manual
6. Comparison of the use of second and third line therapies
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Sources of funding
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Sanofi-Aventis Pharma (UK)
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Trial website
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Publications
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Contact name
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Dr
Riyaz
Shah
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Address
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Kent Oncology Centre
Maidstone Hospital
Hermitage Lane
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City/town
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Maidstone
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Zip/Postcode
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ME16 9QQ
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Country
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United Kingdom
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Sponsor
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Maidstone and Tunbridge Wells NHS Trust (UK)
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Address
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Research Management and Governance Centre
Kent and Medway Primary Care Trust
Ward Block, Preston Hall
Aylesford, Kent
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City/town
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Maidstone
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Zip/Postcode
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ME20 7NJ
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Country
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United Kingdom
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Sponsor website:
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http://www.kentandmedway.nhs.uk/
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Date applied
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09/10/2007
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Last edited
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14/01/2008
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Date ISRCTN assigned
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14/01/2008
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