AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 2NCT00198393

Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

A Phase 2 study testing Gefitinib, gemcitabine and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Gefitinib, gemcitabine and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesFrance
Study dates
Nov 2004to Dec 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU Avicenne - Oncologie

    Bobigny, 93000

  • CHU Grenoble - pneumologie

    Grenoble, 38000

Other trials in France

About this study

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.

Read the detailed description

Arm A Iressa 250 mg daily PROG/TOX --> Taxotere 75 mg/m² d1 (d1=d22)

Arm B Gemzar 1250 mg/m² d1 \& d8 (d1=d22) PROG/TOX --> Iressa 250 mg daily

Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --> Iressa 250 mg daily

Keywords
stage IIIB/IV NSCLC, patients with performance status 2 or 3.
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GefitinibDrug

    250 mg/day, until progression

  • gemcitabineDrug

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

  • DocetaxelDrug

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

Study groups in NCT00198393
Study groupRoleWhat they receive
AExperimentalGefitinib
Receives: Drug: Gefitinib
BExperimentalGemcitabine
Receives: Drug: gemcitabine
CExperimentalDocetaxel
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Measured: week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionJun 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00198393
Sponsor's protocol ID
IFCT-0301
Status last verified
Apr 2010
First submitted
13 Sep 2005
Last updated
30 Apr 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18235404

  • 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.

    PubMed 20400201

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gefitinib, gemcitabine and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00198393, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in