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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
docetaxel
quality-of-life assessment
Sponsored by
UNICANCER
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

70 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Medico-Chirurgical de Creil
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • Centre Hospitalier Intercommunal St. Aubin les Elbeuf
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • Institut Curie Hopital
  • Clinique De Genolier
  • Charing Cross Hospital
  • Centre for Cancer Research and Cell Biology at Belfast City Hospital
  • West of Scotland Cancer Centre

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

Response rate
Overall survival
Progression-free survival
Mood status and autonomy of activity
Toxicity

Full Information

First Posted
September 26, 2005
Last Updated
February 10, 2020
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00227708
Brief Title
Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 29, 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Quality of life
Secondary Outcome Measure Information:
Title
Response rate
Title
Overall survival
Title
Progression-free survival
Title
Mood status and autonomy of activity
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Fargeot, MD
Organizational Affiliation
Centre Georges Francois Leclerc
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Medico-Chirurgical de Creil
City
Creil
ZIP/Postal Code
60107
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
City
Elbeuf
ZIP/Postal Code
76503
Country
France
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Clinique De Genolier
City
Genolier
ZIP/Postal Code
Ch-1272
Country
Switzerland
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

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

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