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A 2 Stage Trial of Lenalidomide (REV) in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse — REV  

Ovarian Cancer Recurrent Clinical Trial

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.

Clinical Trial Summary

Study in two stages, and with a sub-study.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01111903
Study type Interventional
Source ARCAGY/ GINECO GROUP
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 2009
Completion date December 2014
View Details
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