Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer (TOPO-LAPA)

April 27, 2009 updated by: Centre Francois Baclesse

A Phase II Study Evaluating the Association of Topotecan and Lapatinib in Early Recurrent (Less Than 12 Months)Ovarian or Peritoneal Cancer Patients After First Line of Platinum-Based Chemotherapy

The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

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
      • Angers, France, 49933
        • Centre Paul Papin
      • Besancon, France, 25030
        • CHU Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Dijon, France, 21076
        • Centre G-F Leclerc
      • La ROCHE SUR YON, France, 85025
        • CHD Les Oudairies
      • Le MANS, France, 72015
        • Centre Jean Bernard
      • Montpellier, France, 34298
        • Centre Val D'Aurelle
      • Mougins, France, 06250
        • Centre Azuréen de Cancérologie
      • Nancy, France, 54511
        • Centre Alexis Vautrin
      • Nantes, France, 44805
        • Centre Rene Gauducheau
      • Nantes, France, 44202
        • Centre Catherine de Sienne
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75231
        • Institut Curie
      • Paris, France, 75012
        • Hôpital Diaconesses
      • Paris, France, 75970
        • APHP Hôpital Tenon
      • Reims, France, 51056
        • Institut Jean Godinot
      • Saint Etienne, France, 42271
        • Institut de Cancerologie de La Loire
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Villejuif, France, 94805
        • Institut Gustave Roussy
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre Francois Baclesse

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:

  • Age superior or equal 18 years
  • primitive ovarian adenocarcinoma histologically confirmed
  • or peritoneal or fallopian tube adenocarcinoma histologically confirmed
  • Progression or relapse within 12 months after the end of first line of platin based chemotherapy
  • association in first line with other anticancer agent is allowed (taxanes, anthracyclines, alkylants or gemcitabine) and with an anti-angiogenic (bevacizumab, sunitinib).
  • intra-peritoneal chemotherapy in first line is possible
  • No previous treatment with HER inhibitors (ex : gefitinib)
  • HER status not necessary
  • measurable lesions (RECIST criteria). and/or CA125 value higher than 2 fold the normal value or CA125 higher than 2 fold nadir value (if no normalized) proved by two samples distant of 1 month
  • OMS inferior or equal 2.
  • biological parameters as follow: creatininemia ≤ 150 µmol/L or clearance ≥ 50 mL/min,bilirubin ≤ 1,5 LNS,transaminases and or alcalin phosphatases ≤ 2 LNS without hepatic metastasis or ≤ 3 LNS if hepatic metastasis,neutrophils ≥ 1,5.109/L,plaquettes ≥ 100.109/L.
  • normal FEV
  • No previous treatment by chemotherapy, hormonotherapy, immunotherapy or radiotherapy within 4 weeks before inclusion
  • No concomitant treatment forbidden with lapatinib.
  • No previous treatment by Amiodarone in 6 months before inclusion
  • signed informed consent

Exclusion Criteria:

  • Previous treatment with :

    • intensive chemotherapy with autograft
    • two lignes of chemotherapy
    • previous total abdominal irradiation
    • previous chemotherapy with anti-HER treatment
  • History of brain or meningitis metastasis uncontrolled.
  • Malignancies except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer.
  • uncontrolled infectious pathology
  • uncontrolled cardiovascular disease
  • Patients with an active intestinal occlusion not permit oral treatment
  • known hypersensibility to topotecan and its excipients
  • Woman of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
  • Individual deprived of liberty

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.
Time Frame: every two cycles of chemotherapy
every two cycles of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Global survival rate, survival rate without progression, response time, time without progression, safety, quality of life, Caracterisation of biological response (tumor, ascite and blood samples)
Time Frame: each cycle of chemotherapy
each cycle of chemotherapy

Collaborators and Investigators

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

Sponsor

Centre Francois Baclesse

Collaborators

GlaxoSmithKline
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Investigators

  • Principal Investigator: Florence JOLY, MD-PHD, Centre Francois Baclesse

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.

Helpful Links

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

March 1, 2008

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2009

Last Update Submitted That Met QC Criteria

April 27, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-005706-44

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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