A 2 Stage Trial of Lenalidomide (REV) in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse
Study in two stages, and with a sub-study.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Efficacy of lenalidomide as single agent, then DMT of lenalidomise with carboplatin and pegylated liposomal doxorubicin [ Time Frame: Rate of Tumor Response + Stable Disease (at 4 months) / DMT ] [ Designated as safety issue: Yes ]
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.
- Safety profile of lenalidomide as single agent, then in combination [ Time Frame: Response rate, Stable Disease rate at 4 months / MDT ] [ Designated as safety issue: Yes ]
- To determine the safety profile of lenalidomide (type, frequency, severity, and relationship of adverse events to study treatment).
- To assess time to progression (TTP).
- To evaluate the safety profile of the combination therapy.
- To determine the response rate.
- To assess time to progression.
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Phase II: lenalidomide 20 mg/day in continuous regimen. Phase I: lenalidomide 25 mg/day 21 days/28 + carboplatin AUC 5 + caelyx 30 mg/m2
Phase II: 20 mg/day in continuous regimen Phase I: 25 mg/day 21 days/28 with carboplatine AUC 5 + caelyx 30mg/m2
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111903
|Paris, France, 75020|
|Principal Investigator:||Frédéric SELLE, MD||Hôpital Tenon|