Suspended

Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer

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What is being tested

Data Collection

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitlePhase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer 
NCT00075517
Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Suspended

Hopital Avicenne

Bobigny, FranceSee the location
Suspended

Centre Jean Bernard

Le Mans, France
Suspended

Hopital Perpetuel Secours

Levallois-Perret, France
Suspended

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil Les Meaux, France
Suspended12 Study Centers