refractory small cell lungcancer
Conditions
Interventions
Docetaxel infusion 75 mg/m2 , carboplatin AUC = 6 mg/ml•min day 1, every 21
days for 4-6 cycles
Sponsors
Jeroen Bosch Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint(s): time to progression, response duration, safety profile and survival. Recurrence of FN after start of Neulasta or levofloxacin. The difference in cumulative dose and dose intensity in patients without FN (and thus without prophylaxis), in patients receiving secondary prophylaxis with pegfilgrastim and/or patients receiving secondary prophylaxis with levofloxacin. | — |
Countries
Netherlands
Outcome results
None listed