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Ovarian Cancer RecurrentPhase 1/2REVNCT01111903

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

A Phase 1/2 study testing Lenalidomide in people with Ovarian Cancer Recurrent, run by ARCAGY/ GINECO GROUP at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study in two stages, and with a sub-study. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer Recurrent
What is being tested?
Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteFrance
Study dates
May 2009to Dec 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Tenon

    Paris, 75020

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Lenalidomide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Phase II: 20 mg/day in continuous regimen Phase I: 25 mg/day 21 days/28 with carboplatine AUC 5 + caelyx 30mg/m2

Study groups in NCT01111903
Study groupRoleWhat they receive
lenalidomideExperimentalPhase II: lenalidomide 20 mg/day in continuous regimen. Phase I: lenalidomide 25 mg/day 21 days/28 + carboplatin AUC 5 + caelyx 30 mg/m2
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (1)

  1. Safety profile of lenalidomide as single agent, then in combination

    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.

    Measured: Response rate, Stable Disease rate at 4 months / MDT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2010 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01111903
Sponsor's protocol ID
REV (GINECO-OV214)
Acronym
REV
Status last verified
Mar 2016
First submitted
26 Apr 2010
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Selle F, Sevin E, Ray-Coquard I, Mari V, Berton-Rigaud D, Favier L, Fabbro M, Lesoin A, Lortholary A, Pujade-Lauraine E. A phase II study of lenalidomide in platinum-sensitive recurrent ovarian carcinoma. Ann Oncol. 2014 Nov;25(11):2191-2196. doi: 10.1093/annonc/mdu392. Epub 2014 Sep 10.

    PubMed 25210017

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide in people with Ovarian Cancer Recurrent, run by ARCAGY/ GINECO GROUP at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01111903, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.

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