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Brief Title: A 2 Stage Trial of Lenalidomide (REV) in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse
Official Title: A Two Stage Trial of lénalidomide (Revlimid®) : a Phase II Study of lénalidomide as Single Agent in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse: Followed by a Phase I of lénalidomide in Combination With Carboplatin and Liposomal Pegylated Doxorubicin.
Study ID: NCT01111903
Brief Summary: Study in two stages, and with a sub-study.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Hopital Tenon, Paris, , France
Name: Frédéric SELLE, MD
Affiliation: Hôpital Tenon
Role: PRINCIPAL_INVESTIGATOR