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Paclitaxel in Treating Patients With Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
paclitaxel
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Regional de la Citadelle
  • University Thomayers' Hospital
  • Universitaetsklinik und Strahlenklinik - Essen
  • Azienda Ospedale S. Luigi - Universita Di Torino
  • Vrije Universiteit Medisch Centrum

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 29, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00002972
Brief Title
Paclitaxel in Treating Patients With Lung Cancer
Official Title
Phase II Study on TAXOL in Bronchioalveolar Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Scagliotti, MD, PhD
Organizational Affiliation
Azienda Ospedale S. Luigi at University of Torino
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Regional de la Citadelle
City
Liege (Luik)
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University Thomayers' Hospital
City
Krhanice
ZIP/Postal Code
257 42
Country
Czech Republic
Facility Name
Universitaetsklinik und Strahlenklinik - Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Azienda Ospedale S. Luigi - Universita Di Torino
City
Orbassano, (Torino)
ZIP/Postal Code
10043
Country
Italy
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1001HV
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16019107
Citation
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. doi: 10.1016/j.lungcan.2005.05.012.
Results Reference
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Paclitaxel in Treating Patients With Lung Cancer

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