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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Study in two stages, and with a sub-study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

Stage A: Patient:

• 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 or without measurable lesions.

• with disease in progression > 6 months after a first or second line including a platinum derivative. Patients should have received previously a taxane derivative.

• 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 < 2 x upper normal limit of normal range; Estimated glomerular filtration rate > 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.

• Measurable disease by RECIST or evaluable disease by GCIG (CA-125).

• 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. Patients should stop lenalidomide for 7 days before entry in stage B (7 days wash out).

• 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 < 2 x upper normal limit of normal range; Estimated glomerular filtration rate > 50 ml/mn according to Cockroft-Gault formula.

• with LVEF under normal 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.

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, gastrointestinal 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.