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

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ClinicalTrials.gov Identifier: NCT00418743
Recruitment Status : Unknown
Verified March 2010 by Groupe Francais De Pneumo-Cancerologie.
Recruitment status was:  Recruiting
First Posted : January 5, 2007
Last Update Posted : March 9, 2010
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Amgen
Information provided by:
Groupe Francais De Pneumo-Cancerologie

January 4, 2007
January 5, 2007
March 9, 2010
December 2005
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Complete list of historical versions of study NCT00418743 on ClinicalTrials.gov Archive Site
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Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)
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.
Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
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.
Small Cell Lung Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
138
Same as current
May 2010
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00418743
GFPC 05-01
Yes
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Pr CHOUAID, GFPC
Groupe Francais De Pneumo-Cancerologie
  • Baxter Healthcare Corporation
  • Amgen
Principal Investigator: Christos CHOUAID, Professor Groupe Francais De Pneumo-Cancerologie
Groupe Francais De Pneumo-Cancerologie
March 2010