Status:
UNKNOWN
Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)
Lead Sponsor:
Groupe Francais De Pneumo-Cancerologie
Collaborating Sponsors:
Baxter Healthcare Corporation
Amgen
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00418743
Start Date
December 1 2005
End Date
May 1 2010
Last Update
March 9 2010
Active Locations (24)
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1
Centre Hospitalier Universitaire
Angers, France, 49033
2
Site 05
Bastia, France, 20200
3
Site 22
Beauvais, France, 60021
4
Centre Hospitalier du Morvan
Brest, France, 29200