CClinicalTrials.gg
Status unknownNCT00075517Updated Jul 24, 2008

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

A Phase 2 interventional study of docetaxel and gemcitabine hydrochloride in Lung Cancer, sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group. Status unknown at 12 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-07-24.

Sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group is the lead sponsor of 76 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Drugdocetaxel
  • Druggemcitabine hydrochloride
06

What researchers measure

Primary outcomes

  1. Response rate

Secondary outcomes

  1. Progression-free survival

  2. Overall survival

  3. Tolerability

  4. Quality of life

07

Study locations

12 sites
  • Hopital Avicenne
    Bobigny, 93009, France
  • Centre Jean Bernard
    Le Mans, 72000, France
  • Hopital Perpetuel Secours
    Levallois-Perret, 92300, France
  • Centre de Radiotherapie et Oncologie Saint-Faron
    Mareuil Les Meaux, 77100, France
  • Clinique de Docteur Terrioux
    Meaux, 77100, France
  • American Hospital of Paris
    Neuilly Sur Seine, F-92202, France
  • Hopital Tenon
    Paris, 75970, France
  • Clinique les Bleuets
    Reims, 51100, France
  • Polyclinique De Courlancy
    Reims, F-51100, France
  • Centre Rene Huguenin
    Saint Cloud, 92211, France
  • Clinique Francois
    Saint-Dizier, 52100, France
  • Hopital Paul Brousse
    Villejuif, 94804, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00075517
Lead sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
First posted
Jan 12, 2004
Start date
Sep 2003
Last update
Jul 24, 2008

Study contacts

Philippe Terrioux, MD
Clinique de Docteur Terrioux
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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