NCT00198393

Brief Summary

Patients presenting a deterioration of the general state (performance status \[PS\] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment. These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2004

Typical duration for phase_2

Geographic Reach
1 country

2 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

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 30, 2010

Status Verified

April 1, 2010

Enrollment Period

3.6 years

First QC Date

September 13, 2005

Last Update Submit

April 28, 2010

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

stage IIIB/IV NSCLCpatients with performance status 2 or 3.

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS)

    week

Study Arms (3)

A

EXPERIMENTAL

Gefitinib

Drug: Gefitinib

B

EXPERIMENTAL

Gemcitabine

Drug: gemcitabine

C

EXPERIMENTAL

Docetaxel

Drug: Docetaxel

Interventions

GefitinibDRUG

250 mg/day, until progression

A
gemcitabineDRUG

1250 mg/m² D1 and D8 (D1=D28, until progression)

B
DocetaxelDRUG

75 mg/m² D1 (D1=D22, until progression)

C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage IIIB/IV NSCLC
  • patients with performance status 2 or 3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Avicenne - Oncologie

Bobigny, 93000, France

Location

CHU Grenoble - pneumologie

Grenoble, 38000, France

Location

Related Publications (2)

  • Moro-Sibilot D, Pluquet E, Zalcman G, Brechot JM, Souquet PJ, Debieuvre D, Morin F, Morere JF. [What treatment for a patient of PS 2-3 with stage IV non-small cell lung cancer?]. Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S120-4. French.

    PMID: 18235404BACKGROUND

  • Morere JF, Brechot JM, Westeel V, Gounant V, Lebeau B, Vaylet F, Barlesi F, Urban T, Souquet PJ, Debieuvre D, Baudrin L, Zalcman G, Morin F, Milleron B, Moro-Sibilot D. Randomized phase II trial of gefitinib or gemcitabine or docetaxel chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2 or 3 (IFCT-0301 study). Lung Cancer. 2010 Dec;70(3):301-7. doi: 10.1016/j.lungcan.2010.03.003. Epub 2010 Apr 18.

    PMID: 20400201RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

GefitinibGemcitabineDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Jean-Francois Morere, Pr

    Intergroupe Francophone de Cancerologie Thoracique

    PRINCIPAL INVESTIGATOR

  • Denis Moro-Sibilot, Pr

    Intergroupe Francophone de Cancerologie Thoracique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

November 1, 2004

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

April 30, 2010

Record last verified: 2010-04

Locations

FR(2)