Paclitaxel in Treating Patients With Lung Cancer

June 29, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege (Luik), Belgium, 4000
        • Centre Hospitalier Regional De La Citadelle
  • Czech Republic
      • Krhanice, Czech Republic, 257 42
        • University Thomayers' Hospital
  • Germany
      • Essen, Germany, D-45122
        • Universitaetsklinik und Strahlenklinik - Essen
  • Italy
      • Orbassano, (Torino), Italy, 10043
        • Azienda Ospedale S. Luigi - Universita Di Torino
  • Netherlands
      • Amsterdam, Netherlands, 1001HV
        • Vrije Universiteit Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Giorgio Scagliotti, MD, PhD, Azienda Ospedale S. Luigi at University of Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 16, 2003

First Posted (Estimate)

April 17, 2003

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-08956

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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