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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.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer Recurrent

Thank you

Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of lenalidomide as single agent, then DMT of lenalidomise with carboplatin and pegylated liposomal doxorubicin

Outcome Description:

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.

Outcome Time Frame:

Rate of Tumor Response + Stable Disease (at 4 months) / DMT

Safety Issue:

Yes

Principal Investigator

Frédéric SELLE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Tenon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

REV (GINECO-OV214)

NCT ID:

NCT01111903

Start Date:

May 2009

Completion Date:

October 2012

Related Keywords:

  • Ovarian Cancer Recurrent
  • Ovarian Neoplasms

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