Paclitaxel in Treating Patients With Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00002972
First received: November 1, 1999
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study on TAXOL in Bronchioalveolar Carcinoma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Estimated Enrollment: 25
Study Start Date: January 1997
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002972

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

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002972     History of Changes
Other Study ID Numbers: EORTC-08956, EORTC-08956
Study First Received: November 1, 1999
Last Updated: June 29, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014