Compatibility of the topotecan therapy in combination with carboplatin.
The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d
Occurrence of a DLT (Dose Limiting Toxicity)
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
Time frame: after each cycle for up to one year
Progression-free Survival (PFS)
Progression-free survival according to kaplan-meier-estimator
Time frame: after every third cycle, for up to one year
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