Clinical trial · Interventional
Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Quality of life
Secondary outcomes (5)
- measure
- Response rate
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Mood status and autonomy of activity
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available