Ovarian cancer patients in late relapse MedDRA version: 9.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent
Conditions
Interventions
Trade Name: Revlimid 5 mg
Product Name: lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule*
INN or Proposed INN: lenalidomide
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Concent
Sponsors
ARCAGY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage A: Patients - aged > 18 years. - with a histological proven diagnosis of epithelial cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors. - with asymptomatic disease in progression detected by increase of CA 125 levels according to GCIG criteria during systematic follow-up. - with disease in progression > 6 months after a first or second line including a platinum derivative. Patients should have received previously a taxane derivative. - No dose modification in the previous lines of chemiotherapy, nor G-CSF use. - Adequate bone marrow, renal and hepatic function defined as: . WBC > 3.0 x 109/L or Neutrophils (ANC) > 1,5 x 109/L; Platelets > 100 x 109/L; Hemoglobin > 6 mmol/L (10,0 mg/dL); Bilirubin 50 ml/mn according to Cockroft-Gault formula. - with ECOG performance status = 0 or 1. - with a life expectancy of at least 16 weeks - who have given their signed and written informed consent to participate in the trial after fully understanding the implication and constraints of the protocol. Stage B: Patients - aged > 18 years. - with a histological proven diagnosis of epithelial cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors. - with disease in progression > 6 months after a first or second line including a platinum derivative. patients should have received previously a taxane derivative. - Patients included in stage A with disease in progression under lenalidomide could be eligible in phase B if they did not experience unacceptable toxicity under lenalidomide in stage A. - No dose modification in the previous lines of chemiotherapy, nor G-CSF use. - Adequate bone marrow, renal and hepatic function defined as: . WBC > 3.0 x 109/L or Neutrophils (ANC) > 1,5 x 109/L; Platelets > 100 x 109/L; Hemoglobin > 6 mmol/L (10,0 mg/dL); Bilirubin 50 ml/mn according to Cockroft-Gault formula. - with LVEF under noral range - with ECOG performance status = 0 or 1. - with a life expectancy of at least 16 weeks. - who have given their signed and written informed consent to participate in the trial after fully understanding the implication and constraints of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Ovarian tumors of low malignant potential (borderline tumors). - Non-epithelial ovarian or mixed epithelial/non epithelial tumors (e.g. mixed Mullerian tumors). - Patients with a prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin). - Patients who have received previous radiotherapy. - Presence of symptomatic brain metastases. - Patients with a history of seizure disorder or central nervous system disorders; pre-existing motor or sensory neurologic pathology or symptoms > NCI-CTC grade 1. - History of congestive heart failure (NYHA Classification > 2, even if medically controlled. History of clinical and electrocardiographically documented myocardial infarction within the last 6 months. History of atrial or ventricular arrhythmias (= LOWN II). - Thrombosis or anti-thrombosis treatment within 6 months. - History of visceral bleeding, gastro-intestinal ulcer in 6 months. - Obstructive or sub-occlusive disease. - Patients with severe active infection. - Concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy. - Fertile women not using adequate contraceptive methods, or who are pregnant or breast feeding. - Histories of allergy or sentimentality known about the similar chemical compounds in the carboplatine, either in the doxorubicine liposomale pégylée, or in one of the constituents of the lenalidomide. - Patient having developed a knotty erythema characterized by a rash with desquamation during grip(taking) of thalidomide or a medicine similaire. - Previous administration of lenalidomide. - Seropositivity known about the virus of the human immunodeficiency (HIV), or pathology bound to the syndrome of acquired immunodeficiency (AIDS) or hepatitis activates type A, B or C. - Administration of other simultaneous chemotherapeutic drugs, or hormonal therapy, or simultaneous radiotherapy during the study treatment period (hormone replacement therapy is allowed as are steroid antiemetics). - Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: STAGE A: - To determine the safety profile of lenalidomide (type, frequency, severity, and relationship of adverse events to study treatment). - To assess time to progression (TTP). STAGE B: - To evaluate the safety profile of the combination therapy. - To determine the response rate. - To assess time to progression.;Primary end point(s): STAGE A: - Efficacy: Rate of Tumor Response + Stable Disease (at 4 months) Response rate: CA 125 response defined as a > 50% decline from the baseline value present on two consecutive measurements obtained at least 28 days apart (GCIG criteria of response based on CA 125 kinetics). RECIST response for patients with measurable and/or non-measurable tumor at baseline. Stable Disease rate at 4 months: CA 125 stable disease defined according to GCIG criteria. RECIST stable disease for patients with measurable and/or non-measurable tumor at baseline. STAGE B: - MTD (maximum tolerated dose) of lenalidomide when administered in combination with carboplatin and liposomal pegylated doxorubicin. | — |
Countries
France
Outcome results
None listed