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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Groupe Francais De Pneumo-Cancerologie.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Amgen
Information provided by:
Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier:
NCT00418743
First received: January 4, 2007
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

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.


Condition Phase
Small Cell Lung Cancer
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Groupe Francais De Pneumo-Cancerologie:

Estimated Enrollment: 138
Study Start Date: December 2005
Estimated Study Completion Date: May 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418743

Contacts
Contact: Christos CHOUAID, Professor +33 1 49 28 25 16 christos.chouid@sat.ap-hop-paris.fr

Locations
France
Centre Hospitalier Universitaire Recruiting
Angers, France, 49033
Contact: Thierry URBAN, Doctor    +33241355844    thurban@chu-angers.fr   
Principal Investigator: Thierry URBAN, Doctor         
Sub-Investigator: Nathalie BAIZE, Doctor         
Sub-Investigator: Thierry JEANFAIVRE, Doctor         
Sub-Investigator: José HUREAUX, Doctor         
Site 05 Recruiting
Bastia, France, 20200
Contact: Jean Cl MOURIES, Doctor    +33495591080    jcmouries@ch-bastia.fr   
Principal Investigator: Jean Cl MOURIES, Doctor         
Site 22 Recruiting
Beauvais, France, 60021
Contact: Eric BOUCHAERT, Doctor         
Principal Investigator: Eric BOUCHAERT, Doctor         
Centre Hospitalier du Morvan Recruiting
Brest, France, 29200
Contact: Gilles ROBINET, Doctor    +33298223428    gilles.robinet@chu-brest.fr   
Principal Investigator: Gilles ROBINET, Doctor         
Centre François Baclesse Recruiting
Caen, France, 14000
Contact: Radj GERVAIS, Doctor    +33231455013    r.gervais@baclesse.fr   
Principal Investigator: Radj GERVAIS, Doctor         
Site 43 Recruiting
Caen, France, 14000
Contact: Radj GERVAIS, Professor         
Principal Investigator: Radj GERVAIS, Professor         
Centre Hospitalier René Dubos Recruiting
Cergy-pontoise, France, 95301
Contact: Gislaine FRABOULET, Doctor    +33130754282    gislaine.fraboulet@ch-pontoise.fr   
Principal Investigator: Gislaine FRABOULET, Doctor         
Site 33 Recruiting
Creteil, France, 94010
Contact: Isabelle MONNET, Doctor         
Principal Investigator: Isabelle MONNET, Doctor         
Site 07 Recruiting
Draguignan, France, 83300
Contact: Hervé LECAER, Doctor    +33 4 94 60 51 12    herve.lecaer@ch-draguignan.fr   
Principal Investigator: Hervé LE CAER, Doctor         
Site 32 Recruiting
Elbeuf, France, 76503
Contact: Philippe DAVID         
Principal Investigator: Philippe DAVID, Professor         
Site 04 Recruiting
GAP, France, 05000
Contact: Pascal THOMAS, Doctor    +33 4 92 40 61 26    pascal.thomas@chicas-gap.fr   
Principal Investigator: Pascal THOMAS, Doctor         
Centre Hospitalier Les Oudairies Recruiting
La Roche Sur Yon, France, 85000
Contact: Acya BIZIEUX-TAMINY, Doctor    +33251446164    acya.bizieux@chd-vendee.fr   
Principal Investigator: Acya BIZIEUX-TAMINY, Doctor         
Sub-Investigator: Marie MARCQ, Doctor         
Hospital du Cluzeau Recruiting
Limoges, France, 87042
Contact: Alain VERGNENEGRE, Professor    +33 5 55 05 66 29    avergne@unilim.fr   
Principal Investigator: Alain VERGNENEGRE, Professor         
Centre Hospitalier Régional Recruiting
Longjumeau, France, 91160
Contact: Gérard OLIVIERO, Doctor    +33164543181    gerard.oliviero@ch-longjumeau.fr   
Principal Investigator: Gérard OLIVIERO, Doctor         
Sub-Investigator: Pascal ASSOULINE, Doctor         
Centre Hospitalier Lyon Sud Recruiting
Lyon, France, 69495
Contact: Laurence GERINIERE, Doctor    +33478861328    lairence.geriniere@chu-lyon.fr   
Principal Investigator: Laurence GERINIERE, Doctor         
Sub-Investigator: Pierre J SOUQUET, Professor         
Site 25 Recruiting
Mantes La Jolie, France, 78200
Contact: Jean B AULIAC, Doctor         
Principal Investigator: Jean Be AULIAC, Doctor         
Site 06 Recruiting
Marseille, France, 13274
Contact: Fabrice BARLESI, Doctor    +33 4 91 74 47 36    fabrice.barlesi@aphm.fr   
Principal Investigator: Fabrice BARLESI, Professor         
Sub-Investigator: Laurent GREILLIER, Doctor         
Sub-Investigator: Philippe ASTOUL, Professor         
Site 27 Recruiting
Martigues, France, 13695
Contact: Hervé JULLIAN, Doctor         
Principal Investigator: Hervé JULLIAN, Doctor         
Site 01 Recruiting
Meaux, France, 77108
Contact: Francois BLANCHON, Doctor    +33 1 64 35 38 56    f-blanchon@ch-meaux.fr   
Principal Investigator: Francois BLANCHON, Doctor         
Hospital Saint Antoine Recruiting
Paris, France, 75012
Contact: Christos CHOUAID, Professor    +33 1 48 28 25 16    christos.chouaid@sat.ap-hop-paris.fr   
Principal Investigator: Christos CHOUAID, Professor         
Site 17 Recruiting
Rouen, France, 76233
Contact: Dominique PAILLOTIN, DOCTOR         
Principal Investigator: Dominique PAILLOTIN, Doctor         
Hôpital Yves Le Foll Recruiting
Saint Brieuc, France, 22023
Contact: Gwenaelle LE GARFF, Doctor    +33296017123    gwenaelle.legarff@ch-stbrieuc.fr   
Principal Investigator: Gwenaelle LE GARFF, Doctor         
Site 14 Recruiting
Toulon, France, 83800
Contact: Henri BERARD, Doctor         
Principal Investigator: Henri BERARD, Doctor         
Site 11 Recruiting
Villefranche Sur Saone, France, 69655
Contact: Lionel FALCHERO, Doctor    +33 4 74 09 27 23      
Principal Investigator: Lionel FALCHERO, Doctor         
Sponsors and Collaborators
Groupe Francais De Pneumo-Cancerologie
Baxter Healthcare Corporation
Amgen
Investigators
Principal Investigator: Christos CHOUAID, Professor Groupe Francais De Pneumo-Cancerologie
  More Information

Additional Information:
No publications provided

Responsible Party: Pr CHOUAID, GFPC
ClinicalTrials.gov Identifier: NCT00418743     History of Changes
Other Study ID Numbers: GFPC 05-01
Study First Received: January 4, 2007
Last Updated: March 8, 2010
Health Authority: France: Institutional Ethical Committee

Keywords provided by Groupe Francais De Pneumo-Cancerologie:
cancer
Lung cancer
small-cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014