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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Centre Hospitalier Universitaire
Angers, France, 49033
Site 05
Bastia, France, 20200
Site 22
Beauvais, France, 60021
Centre Hospitalier du Morvan
Brest, France, 29200
Centre François Baclesse
Caen, France, 14000
Site 43
Caen, France, 14000
Centre Hospitalier René Dubos
Cergy-pontoise, France, 95301
Site 33
Creteil, France, 94010
Site 07
Draguignan, France, 83300
Site 32
Elbeuf, France, 76503
Site 04
GAP, France, 05000
Centre Hospitalier Les Oudairies
La Roche Sur Yon, France, 85000
Hospital du Cluzeau
Limoges, France, 87042
Centre Hospitalier Régional
Longjumeau, France, 91160
Centre Hospitalier Lyon Sud
Lyon, France, 69495
Site 25
Mantes La Jolie, France, 78200
Site 06
Marseille, France, 13274
Site 27
Martigues, France, 13695
Site 01
Meaux, France, 77108
Hospital Saint Antoine
Paris, France, 75012
Site 17
Rouen, France, 76233
Hôpital Yves Le Foll
Saint Brieuc, France, 22023
Site 14
Toulon, France, 83800
Site 11
Villefranche Sur Saone, France, 69655
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:
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

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 January 23, 2017