A Two Stage Trial of Lenalidomide in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse: a Study of Lenalidomide as Single Agent Followed by Lenalidomide in Combination With Carboplatin and Liposomal Pegylated Doxorubicin
Summary
Study in two stages, and with a sub-study:
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Recurrent Ovarian Cancer in Second or Third Line
Intervention
Lenalidomide
Location
Hopital Tenon
Paris
France
75020
Status
Recruiting
Source
ARCAGY/ GINECO GROUP
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01111903
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Topotecan
An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.
Primary Ovarian Insufficiency
Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.
Ovarian Failure, Premature
Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.
Ovarian Hyperstimulation Syndrome
A complication of OVULATION INDUCTION in infertility treatment. It is graded by the severity of symptoms which include OVARY enlargement, multiple OVARIAN FOLLICLES; OVARIAN CYSTS; ASCITES; and generalized EDEMA. The full-blown syndrome may lead to RENAL FAILURE, respiratory distress, and even DEATH. Increased capillary permeability is caused by the vasoactive substances, such as VASCULAR ENDOTHELIAL GROWTH FACTORS, secreted by the overly-stimulated OVARIES.
Jurkat Cells
A CELL LINE derived from human T-CELL LEUKEMIA and used to determine the mechanism of differential susceptibility to anti-cancer drugs and radiation.
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