NL-OMON33924CompletedPhase 2
A phase II study of docetaxel/carboplatin as secondline treatment in patients with refractory or relapsed SCLC - 2nd line Docetaxel/Carboplatin in patients with SCLC-ED.
Jeroen Bosch Ziekenhuis0 sites50 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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