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Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
docetaxel
gemcitabine hydrochloride
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes: Epidermoid carcinoma Large cell carcinoma Adenocarcinoma Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease Inoperable disease Measurable disease At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Platelet count at least 100,000/mm^3 Absolute neutrophil count at least 2,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Bilirubin no greater than normal Transaminases no greater than 1.5 times normal Alkaline phosphatase no greater than 2.5 times normal Renal Creatinine no greater than 2.3 mg/dL Cardiovascular No uncontrolled cardiac insufficiency Other Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study therapy No uncontrolled infection No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No grade 3 or 4 brain disorder No intolerance to polysorbate 80 or cortisones PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy, including taxanes or gemcitabine No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to more than 20% of the bone marrow No prior radiotherapy for lung cancer At least 4 weeks since other prior radiotherapy and recovered Surgery No prior surgery for lung cancer Other More than 30 days since prior clinical trial participation

Sites / Locations

  • Hopital Avicenne
  • Centre Jean Bernard
  • Hopital Perpetuel Secours
  • Centre de Radiotherapie et Oncologie Saint-Faron
  • Clinique de Docteur Terrioux
  • American Hospital of Paris
  • Hopital Tenon
  • Clinique les Bleuets
  • Polyclinique De Courlancy
  • Centre Rene Huguenin
  • Clinique Francois
  • Hopital Paul Brousse

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Progression-free survival
Overall survival
Tolerability
Quality of life

Full Information

First Posted
January 9, 2004
Last Updated
July 23, 2008
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00075517
Brief Title
Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel. Secondary Determine the progression-free and overall survival of patients treated with this regimen. Determine the tolerance profile of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter study. Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months thereafter. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Response rate
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Overall survival
Title
Tolerability
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes: Epidermoid carcinoma Large cell carcinoma Adenocarcinoma Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease Inoperable disease Measurable disease At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Platelet count at least 100,000/mm^3 Absolute neutrophil count at least 2,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Bilirubin no greater than normal Transaminases no greater than 1.5 times normal Alkaline phosphatase no greater than 2.5 times normal Renal Creatinine no greater than 2.3 mg/dL Cardiovascular No uncontrolled cardiac insufficiency Other Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study therapy No uncontrolled infection No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No grade 3 or 4 brain disorder No intolerance to polysorbate 80 or cortisones PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy, including taxanes or gemcitabine No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to more than 20% of the bone marrow No prior radiotherapy for lung cancer At least 4 weeks since other prior radiotherapy and recovered Surgery No prior surgery for lung cancer Other More than 30 days since prior clinical trial participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Terrioux, MD
Organizational Affiliation
Clinique de Docteur Terrioux
Facility Information:
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Hopital Perpetuel Secours
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
Centre de Radiotherapie et Oncologie Saint-Faron
City
Mareuil Les Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
Clinique de Docteur Terrioux
City
Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
American Hospital of Paris
City
Neuilly Sur Seine
ZIP/Postal Code
F-92202
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Clinique les Bleuets
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Clinique Francois
City
Saint-Dizier
ZIP/Postal Code
52100
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France

12. IPD Sharing Statement

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Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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