Study in two stages, and with a sub-study.
Stage A: To determine efficacy of lenalidomide as single agent in patients with recurrent ovarian cancer in second or third line. Stage B: To determine the Maximum Tolerated Dose (MTD) of lenalidomide in combination with chemotherapy consisting of carboplatin and pegylated liposomal doxorubicin. Substudy: To investigate the impact of the lenalidomide on patients' immune system affected by cancer and to look for an immunizing marker which could be predictive of the activity of the lenalidomide in the solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Phase II: 20 mg/day in continuous regimen Phase I: 25 mg/day 21 days/28 with carboplatine AUC 5 + caelyx 30mg/m2
Hopital Tenon
Paris, France
Efficacy of lenalidomide as single agent, then DMT of lenalidomise with carboplatin and pegylated liposomal doxorubicin
STAGE A: To determine efficacy of lenalidomide as single agent in patients with recurrent ovarian cancer in second or third line. STAGE B: To determine the Maximum Tolerated Dose (MTD) of lenalidomide in combination with chemotherapy consisting of carboplatin and pegylated liposomal doxorubicin.
Time frame: Rate of Tumor Response + Stable Disease (at 4 months) / DMT
Safety profile of lenalidomide as single agent, then in combination
STAGE A: * To determine the safety profile of lenalidomide (type, frequency, severity, and relationship of adverse events to study treatment). * To assess time to progression (TTP). STAGE B: * To evaluate the safety profile of the combination therapy. * To determine the response rate. * To assess time to progression.
Time frame: Response rate, Stable Disease rate at 4 months / MDT
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