A phase II trial of docetaxel in the treatment of elderly patients (aged 70 or over) with non-small cell lung cancer
| ISRCTN | ISRCTN27242710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27242710 |
| Protocol serial number | NSCLC-DOCET_L_02602 |
| Sponsor | Maidstone and Tunbridge Wells NHS Trust (UK) |
| Funder | Sanofi-Aventis Pharma (UK) |
- Submission date
- 09/10/2007
- Registration date
- 14/01/2008
- Last edited
- 01/08/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Kent Oncology Centre
Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Simon 2 stage MiniMax: this is a single arm (non-randomised) phase II trial with 2 stages |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study acronym | ELTAX |
| Study objectives | 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). |
| Ethics approval(s) | In progress through NRES, pending as of 14/01/2008. |
| Health condition(s) or problem(s) studied | Advanced stage non small cell lung cancer |
| Intervention | 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. Please note that as of 01/08/2012 this record was updated to show that the trial was stopped in 2009. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Docetaxel |
| Primary outcome measure(s) |
Response rate, measured by RECIST criteria once all patients have completed protocol defined therapy. |
| Key secondary outcome measure(s) |
1. Progression free survival, measured using the Kaplin Meier method |
| Completion date | 01/01/2009 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 55 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
ME16 9QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
