NCT01111903

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

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Lenalidomide	Phase II: 20 mg/day in continuous regimen Phase I: 25 mg/day 21 days/28 with carboplatine AUC 5 + caelyx 30mg/m2

Timeline

• Start date: 2009-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-04-28
• Last updated: 2016-03-17

Locations

1 site across 1 country: France