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Paclitaxel in Treating Patients With Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002972   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
January 1997
 
 
 
Complete list of historical versions of study NCT00002972 on ClinicalTrials.gov Archive Site
 
 
 
Paclitaxel in Treating Patients With Lung Cancer
Phase II Study on TAXOL in Bronchioalveolar Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.

OBJECTIVES:

  • Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC).
  • Assess the duration of response in patients presenting with an objective response.
  • Characterize the acute side effects of paclitaxel in patients with BAC.
  • Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation.

OUTLINE: This is an open label, nonrandomized, multicenter study.

Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur.

Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs.

PROJECTED ACCRUAL: 16 or 25 patients will be accrued.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Active Control
Lung Cancer
Drug: paclitaxel
 
Scagliotti GV, Smit E, Bosquee L, O'Brien M, Ardizzoni A, Zatloukal P, Eberhardt W, Smid-Geirnaerdt M, de Bruin HG, Dussenne S, Legrand C, Giaccone G; European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group (LCG). A phase II study of paclitaxel in advanced bronchioloalveolar carcinoma (EORTC trial 08956). Lung Cancer. 2005 Oct;50(1):91-6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
25
 
 

DISEASE CHARACTERISTICS:

  • Histologically proven bronchoalveolar carcinoma (BAC) based on these criteria:

    • Absence of primary adenocarcinoma elsewhere
    • Absence of a demonstrable central bronchogenic origin
    • A peripheral location in the lung parenchyma
    • Intact interstitial framework of the lung
    • A histological appearance setting it apart from other tumors, with a characteristic pattern of growth: cuboidal or cylindrical cells lining up the alveolar septa with preservation of basic pulmonary architecture
  • Must be unresectable Stage IIIB, IV, or recurrent BAC
  • Evidence of multinodular lesions involving the lungs bilaterally or unilaterally (in the latter the lesions must involve more than one lobe)
  • At least one target lesion bidimensionally measurable that has not undergone prior irradiation
  • No CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75 (inclusive)

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 3 months

Hematopoietic:

  • ANC at least 1,500/mm^3

Hepatic:

  • Bilirubin less than 2 times upper limit of normal
  • SGOT, SGPT, and alkaline phosphatase less than 2 times upper limit of normal

Renal:

  • Creatinine less than 1.5 times upper limit of normal

Cardiovascular:

  • No history of ischemic or congestive heart disease
  • No arrhythmia requiring chronic cardiopulmonary medications
  • No history of clinically or electrographically documented myocardial infarction

Other:

  • No preexisting motor or other serious sensory neurotoxicity
  • No active or prior second primary cancer except basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No clinical evidence of uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test 72 hours prior to start of study medication
  • Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since radiotherapy
  • Must have at least one bidimensional lesion outside the irradiated fields

Surgery:

  • Fully recovered from any prior major surgery
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Germany,   Italy,   Netherlands
 
NCT00002972
 
CDR0000065481, EORTC-08956
European Organization for Research and Treatment of Cancer
 
Study Chair: Giorgio Scagliotti, MD, PhD Azienda Ospedale S. Luigi at University of Torino
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP