Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)

March 8, 2010 updated by: Groupe Francais De Pneumo-Cancerologie

A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.

The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

Study Overview

Status

Unknown

Conditions

Detailed Description

Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

Study Type

Observational

Enrollment (Anticipated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49033
        • Recruiting
        • Centre Hospitalier Universitaire
        • Contact:
        • Principal Investigator:
          • Thierry URBAN, Doctor
        • Sub-Investigator:
          • José HUREAUX, Doctor
      • Bastia, France, 20200
        • Recruiting
        • Site 05
        • Contact:
        • Principal Investigator:
          • Jean Cl MOURIES, Doctor
      • Beauvais, France, 60021
        • Recruiting
        • Site 22
        • Contact:
          • Eric BOUCHAERT, Doctor
        • Principal Investigator:
          • Eric BOUCHAERT, Doctor
      • Brest, France, 29200
        • Recruiting
        • Centre Hospitalier du Morvan
        • Contact:
        • Principal Investigator:
          • Gilles ROBINET, Doctor
      • Caen, France, 14000
        • Recruiting
        • Centre François Baclesse
        • Contact:
        • Principal Investigator:
          • Radj GERVAIS, Doctor
      • Caen, France, 14000
        • Recruiting
        • Site 43
        • Contact:
          • Radj GERVAIS, Professor
        • Principal Investigator:
          • Radj GERVAIS, Professor
      • Cergy-pontoise, France, 95301
        • Recruiting
        • Centre Hospitalier Rene Dubos
        • Contact:
        • Principal Investigator:
          • Gislaine FRABOULET, Doctor
      • Creteil, France, 94010
        • Recruiting
        • Site 33
        • Contact:
          • Isabelle MONNET, Doctor
        • Principal Investigator:
          • Isabelle MONNET, Doctor
      • Draguignan, France, 83300
        • Recruiting
        • Site 07
        • Contact:
        • Principal Investigator:
          • Hervé LE CAER, Doctor
      • Elbeuf, France, 76503
        • Recruiting
        • Site 32
        • Contact:
          • Philippe DAVID
        • Principal Investigator:
          • Philippe DAVID, Professor
      • GAP, France, 05000
        • Recruiting
        • Site 04
        • Contact:
        • Principal Investigator:
          • Pascal THOMAS, Doctor
      • La Roche Sur Yon, France, 85000
        • Recruiting
        • Centre Hospitalier Les Oudairies
        • Contact:
        • Principal Investigator:
          • Acya BIZIEUX-TAMINY, Doctor
        • Sub-Investigator:
          • Marie MARCQ, Doctor
      • Limoges, France, 87042
        • Recruiting
        • Hospital du Cluzeau
        • Contact:
          • Alain VERGNENEGRE, Professor
          • Phone Number: +33 5 55 05 66 29
          • Email: avergne@unilim.fr
        • Principal Investigator:
          • Alain VERGNENEGRE, Professor
      • Longjumeau, France, 91160
        • Recruiting
        • Centre Hospitalier Régional
        • Contact:
        • Principal Investigator:
          • Gérard OLIVIERO, Doctor
        • Sub-Investigator:
          • Pascal ASSOULINE, Doctor
      • Lyon, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
        • Principal Investigator:
          • Laurence GERINIERE, Doctor
        • Sub-Investigator:
          • Pierre J SOUQUET, Professor
      • Mantes La Jolie, France, 78200
        • Recruiting
        • Site 25
        • Contact:
          • Jean B AULIAC, Doctor
        • Principal Investigator:
          • Jean Be AULIAC, Doctor
      • Marseille, France, 13274
        • Recruiting
        • Site 06
        • Contact:
        • Principal Investigator:
          • Fabrice BARLESI, Professor
        • Sub-Investigator:
          • Laurent GREILLIER, Doctor
        • Sub-Investigator:
          • Philippe ASTOUL, Professor
      • Martigues, France, 13695
        • Recruiting
        • Site 27
        • Contact:
          • Hervé JULLIAN, Doctor
        • Principal Investigator:
          • Hervé JULLIAN, Doctor
      • Meaux, France, 77108
        • Recruiting
        • Site 01
        • Contact:
        • Principal Investigator:
          • Francois BLANCHON, Doctor
      • Paris, France, 75012
        • Recruiting
        • Hospital Saint Antoine
        • Contact:
        • Principal Investigator:
          • Christos CHOUAID, Professor
      • Rouen, France, 76233
        • Recruiting
        • Site 17
        • Contact:
          • Dominique PAILLOTIN, DOCTOR
        • Principal Investigator:
          • Dominique PAILLOTIN, Doctor
      • Saint Brieuc, France, 22023
        • Recruiting
        • Hôpital Yves Le Foll
        • Contact:
        • Principal Investigator:
          • Gwenaelle LE GARFF, Doctor
      • Toulon, France, 83800
        • Recruiting
        • Site 14
        • Contact:
          • Henri BERARD, Doctor
        • Principal Investigator:
          • Henri BERARD, Doctor
      • Villefranche Sur Saone, France, 69655
        • Recruiting
        • Site 11
        • Contact:
          • Lionel FALCHERO, Doctor
          • Phone Number: +33 4 74 09 27 23
        • Principal Investigator:
          • Lionel FALCHERO, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Small-cell lung cancer who, after (at least) a first line of chemotherapy based on platinum, had a partial response and then progressed, or who had a complete response and then relapsed within three months following the last course of this first-line therapy.

Description

Inclusion Criteria:

  • Small-cell lung cancer.
  • Patients who, after (at least) a first line of chemotherapy based on platinum, had a partial response and then progressed, or who had a complete response and then relapsed within three months following the last course of this first-line therapy.
  • Measurable or assessable disease.
  • Life expectancy >2 months.
  • Patients with a therapeutic risk level of <5 points (see section 6: "Treatment flowchart").
  • Age >18 years;
  • Performance status (WHO) <2;
  • One measurable target lesion in a non irradiated region;
  • Prior radiotherapy authorized unless it targeted the only measurable lesion;
  • Biological criteria: WBC >2000/mm3, PMN >1500/mm3, platelets >100 000/mm3, creatinemia <2 x ULN, bilirubinemia <ULN, ALT and AST <2.5 x ULN (< 5 N if liver metastases)
  • normal ECG
  • written informed consent.

Exclusion Criteria:

  • Non small-cell lung cancer.
  • No objective response to platinum-based therapy
  • Complete response lasting more than three months after the last course of first-line treatment.
  • Symptomatic brain metastases.
  • Bone metastases, carcinomatous lymphangitis, ascites or pleurisy as sole assessable disease manifestations.- Concurrent participation in another clinical trial.
  • Therapeutic risk level of 6 points or more (see table)
  • Uncontrolled clotting disorders;
  • Uncontrolled severe infection;
  • History of another malignancy, except for cervical carcinoma in situ or basocellular cancer that are considered cured;
  • Psychological, familial, sociological or geographic circumstances preventing treatment follow-up as defined in the protocol;
  • Patients deprived of their rights for administrative or legal reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Francais De Pneumo-Cancerologie

Collaborators

Baxter Healthcare Corporation
Amgen

Investigators

  • Principal Investigator: Christos CHOUAID, Professor, Groupe Francais De Pneumo-Cancerologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (ANTICIPATED)

May 1, 2010

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (ESTIMATE)

January 5, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 8, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFPC 05-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Cell Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe