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

NCT01111903 | Completed Phase 1 DMC

• 1 other identifier: REV (GINECO-OV214)
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer Recurrent

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Safety profile of lenalidomide as single agent, then in combination

  Response rate, Stable Disease rate at 4 months / MDT

Study Arms (1)

lenalidomide

EXPERIMENTAL

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

Interventions

Lenalidomide DRUG

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

lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead

Study Sites (1)

Hopital Tenon

Paris, 75020, France

Location

Related Publications (1)

• 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.

  PMID: 25210017 DERIVED

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Frédéric SELLE, MD

  Hôpital Tenon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: May 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

FR (1)