Lung CancerPhase 2NCT00227708
Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing docetaxel and quality-of-life assessment in people with Lung Cancer, run by UNICANCER at 9 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in older patients. Read more about this study
- Who is it for?
- Ages 70 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- docetaxel and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Jun 2005to 29 Aug 2006
- Phase
- Phase 2
- 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 70 to 120 years
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combination of these histologies
- Stage IIIB (i.e., pleural T4) disease
- Stage IV disease
- Recurrent disease after prior surgery or radiotherapy allowed provided disease is in an area that was not previously irradiated
- Measurable disease by CT scan or MRI
- No symptomatic brain metastasis
- Activity of Daily Living Scale score ≥ 4
- Instrumental Autonomy of Daily Living Scale score ≥ 4
PATIENT CHARACTERISTICS:
Age
- 70 and over
Performance status
- Not specified
Life expectancy
- More than 3 months
Hematopoietic
- Neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 10 g/dL
Hepatic
- Transaminases < 1.5 times normal
- Bilirubin normal
- Alkaline phosphatase < 2.5 times normal
- Pre-albumin > 1.5 mg/dL
Renal
- Creatinine clearance > 30 mL/min
Cardiovascular
- No congestive heart failure
- No unstable angina pectoris
- No myocardial infarction within the past year
- No uncontrolled hypertension
- No uncontrolled high-risk arrhythmias
Gastrointestinal
- No active peptic ulcer
- No inflammatory bowel disease
Neurologic
- No history of dementia or seizures that would preclude giving informed consent
- No peripheral neuropathy ≥ grade 2
- No history of significant neurologic disorders
Immunologic
- No history of hypersensitivity to the study drug or drugs formulated with polysorbate 80
- No active uncontrolled infection
Other
- No history of psychotic disorders
- No uncontrolled diabetes mellitus
- No absolute contraindication to corticosteroid use
- No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No geriatric depression scale score ≥ 12/15
- No familial, social, geographical, or psychological reason that would preclude study follow up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for stage IIIB or IV non-small cell lung cancer
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent chronic treatment with corticosteroids except low-dose (i.e., methylprednisolone ≤ 20 mg/day or equivalent) treatment that was initiated > 6 months ago
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
Other
- More than 30 days since prior active participation in another therapeutic clinical trial
- No other concurrent anticancer therapy
- No other concurrent investigational drugs
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
France5 sites
Centre Medico-Chirurgical de Creil
Creil, 60107
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
Elbeuf, 76503
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
Institut Curie Hopital
Paris, 75248
United Kingdom3 sites
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB
West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT
Charing Cross Hospital
London, England, W6 8RF
About this study
Official title: Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in older patients.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine the overall survival and progression-free survival of patients treated with this drug.
- Determine the mood status and autonomy of activity of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV twice in week 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed during study therapy in weeks 3-4, 7-8, and 11-12, and then at 6 and 12 months after completion of study treatment.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- docetaxel, quality-of-life assessment
- Keywords
- adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Secondary outcomes (5)
Response rate
Overall survival
Progression-free survival
Mood status and autonomy of activity
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJun 2005
- Study completion29 Aug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Investigators
- Pierre Fargeot, MD, Study chair, Centre Georges Francois Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227708
- Sponsor's protocol ID
- CDR0000443593
- Other IDs
- FRE-FNCLCC-GERICO-05/0501, EU-20521
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2005
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70
- ClinicalTrials.gov ID
- NCT00227708
- Acronym / sponsor ID
- CDR0000443593
- Conditions
- Lung Cancer
- Keywords
- adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- 29 Aug 2006 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in older patients.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine the overall survival and progression-free survival of patients treated with this drug.
- Determine the mood status and autonomy of activity of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV twice in week 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed during study therapy in weeks 3-4, 7-8, and 11-12, and then at 6 and 12 months after completion of study treatment.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 70 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Quality of life
5 secondary outcomes
Response rate
Overall survival
Progression-free survival
Mood status and autonomy of activity
Toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Fargeot, MD study chair
Centre Georges Francois Leclerc
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and quality-of-life assessment in people with Lung Cancer, run by UNICANCER at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, United Kingdom, Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2020.