Paclitaxel in Treating Patients With 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: NCT00002972
Recruitment Status : Completed
First Posted : April 17, 2003
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: paclitaxel Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study on TAXOL in Bronchioalveolar Carcinoma
Study Start Date : January 1997
Actual Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Paclitaxel

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 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



  • 18 to 75 (inclusive)

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 3 months


  • ANC at least 1,500/mm^3


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


  • Creatinine less than 1.5 times upper limit of normal


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


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


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


  • Fully recovered from any prior major surgery

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): NCT00002972

Centre Hospitalier Regional de la Citadelle
Liege (Luik), Belgium, 4000
Czech Republic
University Thomayers' Hospital
Krhanice, Czech Republic, 257 42
Universitaetsklinik und Strahlenklinik - Essen
Essen, Germany, D-45122
Azienda Ospedale S. Luigi - Universita Di Torino
Orbassano, (Torino), Italy, 10043
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1001HV
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Giorgio Scagliotti, MD, PhD Azienda Ospedale S. Luigi at University of Torino

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00002972     History of Changes
Other Study ID Numbers: EORTC-08956
First Posted: April 17, 2003    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action