Lenalidomide and Doxorubicin Hydrochloride Liposome in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with doxorubicin hydrochloride liposome may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with doxorubicin hydrochloride liposome in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Peritoneal Cavity Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||WCC #50 - Phase I/II Trial of Lenalidomide in Combination With Liposomal Doxorubicin for the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer|
- Maximum Tolerated Dose of Lenalidomide [ Time Frame: Beginning from 1st Dose Until Not Tolerated - Phase I ] [ Designated as safety issue: Yes ]Phase I of study: Lenalidomide at cohort specific assigned dose and schedule (starting at 10 mg by mouth per day on days 1-28) of a 28 day cycle with 40 mg/m^2 of liposomal doxorubicin given intravenously (IV) on day 1 of a 28 day cycle.
- Disease Response At Maximum Tolerated Dose [ Time Frame: 3 and 6 Months ] [ Designated as safety issue: No ]Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria defined as one or more lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as > or = 20 mm with conventional techniques (CT, PET/CT, MRI, X-ray) or as > or = 10 mm with spiral CT scan.
- Time to Disease Progression With Maximum Tolerated Dose [ Time Frame: Beginning from 1st Dose Until Disease Progression ] [ Designated as safety issue: No ]RECIST Criteria: Complete Response (CR)- The disappearance of all target lesions. Partial Response (PR)- At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Progressive Disease (PD)- At least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesion(s). Stable Disease (SD)- Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide with liposomal doxorubicin
Patients treated with a combination of lenalidomide and liposomal doxorubicin fpr recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.
Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle
Other Name: RevlimidDrug: pegylated liposomal doxorubicin hydrochloride
Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle
Other Name: Caelyx®
Phase I - Primary
- To determine the maximum tolerated dose of lenalidomide when combined with fixed dose pegylated liposomal doxorubicin hydrochloride in women with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Phase II - Define the best overall response induced by lenalidomide in recurrent ovarian cancer patients
- To obtain preliminary information on toxicity, response, and time to progression (duration of response) of these patients.
- Progression free survival
Phase I OUTLINE: This is a dose-escalation study of lenalidomide. Patients receive oral lenalidomide once daily on days 1-28 and pegylated liposomal doxorubicin hydrochloride intravenously (IV) on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Phase II OUTLINE: The phase II component will include patients with measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria treated at lenalidomide 10 mg days 1-28 days of a 28 day cycle (Maximum Tolerated Dose from phase I) with liposomal doxorubicin 40 mg/m^2 to determine efficacy and safety of the combination therapy. (Effective with April 2010 revision)
After completion of study therapy, patients are followed periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903630
|United States, Minnesota|
|University of Minnesota Medical Center - Fairview|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Levi S. Downs, MD||Masonic Cancer Center, University of Minnesota|