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

July 23, 2008 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Le Mans, France, 72000
        • Centre Jean Bernard
      • Levallois-Perret, France, 92300
        • Hopital Perpetuel Secours
      • Mareuil Les Meaux, France, 77100
        • Centre de Radiotherapie et Oncologie Saint-Faron
      • Meaux, France, 77100
        • Clinique de Docteur Terrioux
      • Neuilly Sur Seine, France, F-92202
        • American Hospital of Paris
      • Paris, France, 75970
        • Hôpital Tenon
      • Reims, France, F-51100
        • Polyclinique de Courlancy
      • Reims, France, 51100
        • Clinique les Bleuets
      • Saint Cloud, France, 92211
        • Centre René Huguenin
      • Saint-Dizier, France, 52100
        • Clinique Francois
      • Villejuif, France, 94804
        • Hopital Paul Brousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
Quality of life
Tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Philippe Terrioux, MD, Clinique de Docteur Terrioux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 11, 2004

First Posted (Estimate)

January 12, 2004

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000346806
  • FRE-GERCOR-DOCEGEM-B00-2
  • EU-20331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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