Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT00227708 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000443593FRE-FNCLCC-GERICO-05/0501EU-20521
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 9

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 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

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

Outcome Measures

Primary Outcomes (1)

• Quality of life

Secondary Outcomes (5)

• Response rate

• Overall survival

• Progression-free survival

• Mood status and autonomy of activity

• Toxicity

Interventions

docetaxel DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (9)

Centre Medico-Chirurgical de Creil

Creil, 60107, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Intercommunal St. Aubin les Elbeuf

Elbeuf, 76503, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Clinique De Genolier

Genolier, Ch-1272, Switzerland

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Belfast City Hospital

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Pierre Fargeot, MD

  Centre Georges Francois Leclerc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: June 1, 2005
• Study Completion: August 29, 2006
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

FR (5); GB (3); CH (1)