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Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: August 10, 2001   Last Updated: August 19, 2009   History of Changes
Sponsor: Istituto Nazionale per lo Studio e la Cura dei Tumori
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022022
  Purpose

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 Intervention Phase
Lung Cancer
 Drug: docetaxel
Procedure: quality-of-life assessment
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Quality of life [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2000
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.25 times ULN

Cardiovascular:

  • No prior or concurrent cardiovascular disease that would preclude study

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy allowed
  • No concurrent radiotherapy

Surgery:

  • Prior radical surgery for NSCLC allowed
  • Concurrent palliative surgery allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022022

Locations
Italy
Azienda Ospedaliena G. Rummo
Benevento, Italy, 82100
Azienda Ospedaliera Policlinico Paolo Giaccone
Palermo, Italy, 90127
Federico II University Medical School
Naples, Italy, 80131
Istituto Di Ricovero E Cura A Carattere Scientifico
Bari, Italy, 70126
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Ospedale Cardarelli - Campobasso
Campobasso, Italy
Ospedale Civile Cosenza
Cosenza, Italy, 87100
Ospedale Civile P.F. Calvi
Noale, Italy
Seconda Universita di Napoli
Naples, Italy, 80133
Ospedale La Maddalena - Palermo
Palermo, Italy
Ospedale Luigi Sacco
Milan, Italy, 20157
Ospedale San Carlo
Potenza, Italy, 85100
Ospedale San Giuseppe
Milan, Italy, 20153
Ospedale San Paolo
Milano, Italy, 20142
Ospedale Vincenzo Monaldi
Naples, Italy, 80131
Ospedale da Procida
Salerno, Italy
Sponsors and Collaborators
Istituto Nazionale per lo Studio e la Cura dei Tumori
Investigators
Study Chair: Cesare Gridelli, MD Istituto Nazionale per lo Studio e la Cura dei Tumori
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Gridelli C, Gallo C, Di Maio M, Barletta E, Illiano A, Maione P, Salvagni S, Piantedosi FV, Palazzolo G, Caffo O, Ceribelli A, Falcone A, Mazzanti P, Brancaccio L, Capuano MA, Isa L, Barbera S, Perrone F. A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study. Br J Cancer. 2004 Dec 13;91(12):1996-2004.
Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2007 Apr 10;25(11):1377-82.

Study ID Numbers: CDR0000068702, ITA-INTN-DISTAL, EU-20103
Study First Received: August 10, 2001
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00022022     History of Changes
Health Authority: United States: Federal Government

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:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms
 Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009



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