The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Amrubicin 45mg/m\<2\> IV days 1, 2 3 of each 21-day cycle until disease progression. Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression.
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus Cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression. Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Time frame: Until Disease Progression
Toxicity
Time frame: Until 30 days after last protocol treatment
Progression-free survival
Time frame: Until disease progression or death
Overall survival
Time frame: Until death
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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