Status:
COMPLETED
Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
UNICANCER
Conditions:
Lung Cancer
Eligibility:
All Genders
70-120 years
Phase:
PHASE2
Brief 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 ma...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 29 2006
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00227708
Start Date
June 1 2005
End Date
August 29 2006
Last Update
February 13 2020
Active Locations (9)
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1
Centre Medico-Chirurgical de Creil
Creil, France, 60107
2
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
3
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
Elbeuf, France, 76503
4
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273