Suspended

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

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What is being tested

docetaxel

+ gemcitabine hydrochloride
Drug
Who is being recruted

Lung Cancer

From 18 to 75 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003

Summary

Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: July 24, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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. 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 
Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: July 24, 2008
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.
Design Details
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.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lung Cancer
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 AvicenneBobigny, FranceSee the location
Suspended
Centre Jean BernardLe Mans, France
Suspended
Hopital Perpetuel SecoursLevallois-Perret, France
Suspended
Centre de Radiotherapie et Oncologie Saint-FaronMareuil Les Meaux, France

Suspended12 Study Centers