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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888810
Recruitment Status : Terminated (lack of efficacy (intermediate analysis))
First Posted : April 28, 2009
Last Update Posted : April 28, 2009
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Information provided by:
Centre Francois Baclesse

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Ovarian Relapse Chemotherapy Drug: TOPOTECAN Drug: LAPATINIB Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    IV administration on Day 1, day 8 and day 15, at the dose level of 3.2 mg/m² for 6 cycles of 28 days(up to 8 cycles)
    Other Name: HYCAMTIN
    Daily oral administration during all the study. 1250 mg/day
    Other Name: TYVERB

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

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00888810

Centre François Baclesse
Caen, Calvados, France, 14076
Centre Paul Papin
Angers, France, 49933
Besancon, France, 25030
Institut Bergonié
Bordeaux, France, 33076
Centre G-F Leclerc
Dijon, France, 21076
CHD Les Oudairies
La ROCHE SUR YON, France, 85025
Centre Jean Bernard
Le MANS, France, 72015
Centre Val d'Aurelle
Montpellier, France, 34298
Centre azuréen de cancérologie
Mougins, France, 06250
Centre Alexis vautrin
Nancy, France, 54511
Centre Catherine de Sienne
Nantes, France, 44202
Centre René Gauducheau
Nantes, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Hôpital Diaconesses
Paris, France, 75012
Institut CURIE
Paris, France, 75231
Paris, France, 75970
Institut Jean Godinot
Reims, France, 51056
Institut de Cancérologie de la Loire
Saint Etienne, France, 42271
Centre Paul Strauss
Strasbourg, France, 67065
Institut Claudius regaud
Toulouse, France, 31052
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Francois Baclesse
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Principal Investigator: Florence JOLY, MD-PHD Centre François Baclesse

Additional Information:
Responsible Party: Pr Florence JOLY - MD-PHD, Centre François Baclesse Identifier: NCT00888810     History of Changes
Other Study ID Numbers: 2007-005706-44
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009

Keywords provided by Centre Francois Baclesse:
ovarian - cancer - relapse - topotecan - lapatinib

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors