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Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022022
Recruitment Status : Unknown
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: docetaxel Procedure: quality-of-life assessment Phase 3

Detailed Description:


  • Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy.
  • Compare the toxicity of these regimens in these patients.
  • Compare the response rate, time to progression, and survival of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a maximum of 6 courses.
  • Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8 weeks for a maximum of 2 courses.

Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
Study Start Date : December 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Primary Outcome Measures :
  1. Quality of life
  2. Toxicity
  3. Response rate
  4. Time to progression
  5. Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)

    • Metastatic supraclavicular lymphadenopathy or malignant pleural effusion
    • Progressive disease
    • Must have received prior chemotherapy
  • No symptomatic brain metastases



  • 18 to 75

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 1.25 times ULN


  • Creatinine no greater than 1.25 times ULN


  • No prior or concurrent cardiovascular disease that would preclude study


  • See Disease Characteristics
  • No prior or concurrent pulmonary disease that would preclude study


  • No prior or other concurrent illness or medical condition that would preclude study
  • No other prior malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No prior docetaxel
  • At least 3 weeks since other prior chemotherapy

Endocrine therapy:

  • Not specified


  • Prior radiotherapy allowed
  • No concurrent radiotherapy


  • Prior radical surgery for NSCLC allowed
  • Concurrent palliative surgery allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022022

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Istituto Di Ricovero E Cura A Carattere Scientifico
Bari, Italy, 70126
Azienda Ospedaliena G. Rummo
Benevento, Italy, 82100
Ospedale Cardarelli - Campobasso
Campobasso, Italy
Ospedale Civile Cosenza
Cosenza, Italy, 87100
Ospedale San Paolo
Milano, Italy, 20142
Ospedale San Giuseppe
Milan, Italy, 20153
Ospedale Luigi Sacco
Milan, Italy, 20157
Federico II University Medical School
Naples, Italy, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Ospedale Vincenzo Monaldi
Naples, Italy, 80131
Seconda Universita di Napoli
Naples, Italy, 80133
Ospedale Civile P.F. Calvi
Noale, Italy
Azienda Ospedaliera Policlinico Paolo Giaccone
Palermo, Italy, 90127
Ospedale La Maddalena - Palermo
Palermo, Italy
Ospedale San Carlo
Potenza, Italy, 85100
Ospedale da Procida
Salerno, Italy
Sponsors and Collaborators
Istituto Nazionale per lo Studio e la Cura dei Tumori
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Study Chair: Cesare Gridelli, MD Istituto Nazionale per lo Studio e la Cura dei Tumori
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00022022    
Other Study ID Numbers: CDR0000068702
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: April 2006
Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action