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A phase II study of docetaxel/carboplatin as secondline treatment in patients with refractory or relapsed SCLC

Phase 2
Completed
Conditions
refractory small cell lungcancer
SCLC-ED
10006436
Registration Number
NL-OMON33924
Lead Sponsor
Jeroen Bosch Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

Histologically proven SCLC at the first diagnosis.
Refractory or relapsed SCLC
Measurable disease according to RECIST criteria
Patients must have fully recovered from toxic effects of previous antitumour therapy.
Age > 18 years.
WHO performance status 0,1 or 2 (Appendix II).

Exclusion Criteria

More than one line of chemotherapy for metastatic disease
Pregnant or lactating women or women of childbearing potential not adhering to adequate anti conceptive measures
History of other invasive malignancy within the last 5 years (other than non melanoma skin cancer or excised cervical carcinoma in situ).
Clinical evidence CNS metastasis.
Symptomatic peripheral neuropathy > grade 2 according (NCI CTC, Appendix III)
Definite contraindications for the use of corticosteroids

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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