NCT00002972

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 lung-cancer

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 17, 2003

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

5.6 years

First QC Date

November 1, 1999

Last Update Submit

June 29, 2012

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung canceradenocarcinoma of the lung

Interventions

paclitaxelDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier Regional de la Citadelle

Liege (Luik), 4000, Belgium

Location

University Thomayers' Hospital

Krhanice, 257 42, Czechia

Location

Universitaetsklinik und Strahlenklinik - Essen

Essen, D-45122, Germany

Location

Azienda Ospedale S. Luigi - Universita Di Torino

Orbassano, (Torino), 10043, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1001HV, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 16019107RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Giorgio Scagliotti, MD, PhD

    Azienda Ospedale S. Luigi at University of Torino

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 17, 2003

Study Start

January 1, 1997

Primary Completion

August 1, 2002

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

IT(1)BE(1)CZ(1)DE(1)NL(1)