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

March 15, 2016 updated by: ARCAGY/ GINECO GROUP

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75020
        • Hôpital Tenon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lenalidomide
Phase II: lenalidomide 20 mg/day in continuous regimen. Phase I: lenalidomide 25 mg/day 21 days/28 + carboplatin AUC 5 + caelyx 30 mg/m2
Drug: Lenalidomide
Phase II: 20 mg/day in continuous regimen Phase I: 25 mg/day 21 days/28 with carboplatine AUC 5 + caelyx 30mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of lenalidomide as single agent, then DMT of lenalidomise with carboplatin and pegylated liposomal doxorubicin
Time Frame: Rate of Tumor Response + Stable Disease (at 4 months) / DMT

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety profile of lenalidomide as single agent, then in combination
Time Frame: Response rate, Stable Disease rate at 4 months / MDT

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.
Response rate, Stable Disease rate at 4 months / MDT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Frédéric SELLE, MD, Hôpital Tenon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REV (GINECO-OV214)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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