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

This study has been terminated.
(lack of efficacy (intermediate analysis))
Sponsor:
Collaborators:
GlaxoSmithKline
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT00888810
First received: April 27, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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 Intervention Phase
Cancer
Ovarian
Relapse
Chemotherapy
Drug: TOPOTECAN
Drug: LAPATINIB
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: March 2008
Intervention Details:
    Drug: TOPOTECAN
    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
    Drug: LAPATINIB
    Daily oral administration during all the study. 1250 mg/day
    Other Name: TYVERB
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888810

Locations
France
Centre François Baclesse
Caen, Calvados, France, 14076
Centre Paul Papin
Angers, France, 49933
CHU Jean MINJOZ
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 René Gauducheau
Nantes, France, 44805
Centre Catherine de Sienne
Nantes, France, 44202
Centre Antoine Lacassagne
Nice, France, 06189
APHP Hopital TENON
Paris, France, 75970
Institut CURIE
Paris, France, 75231
Hôpital Diaconesses
Paris, France, 75012
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
GlaxoSmithKline
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Investigators
Principal Investigator: Florence JOLY, MD-PHD Centre François Baclesse
  More Information

Additional Information:
No publications provided

Responsible Party: Pr Florence JOLY - MD-PHD, Centre François Baclesse
ClinicalTrials.gov Identifier: NCT00888810     History of Changes
Other Study ID Numbers: 2007-005706-44
Study First Received: April 27, 2009
Last Updated: April 27, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Lapatinib
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014