Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer
NCT ID: NCT00888810
Last Updated: 2009-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
39 participants
INTERVENTIONAL
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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)
LAPATINIB
Daily oral administration during all the study. 1250 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
OTHER
Centre Francois Baclesse
OTHER
Responsible Party
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Centre François Baclesse
Principal Investigators
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Florence JOLY, MD-PHD
Role: PRINCIPAL_INVESTIGATOR
Centre François Baclesse
Locations
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Centre François Baclesse
Caen, CALVADOS, France
Centre Paul Papin
Angers, , France
CHU Jean MINJOZ
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre G-F Leclerc
Dijon, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
Centre Jean Bernard
Le Mans, , France
Centre Val d'Aurelle
Montpellier, , France
Centre azuréen de cancérologie
Mougins, , France
Centre Alexis vautrin
Nancy, , France
Centre Catherine de Sienne
Nantes, , France
Centre René Gauducheau
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Diaconesses
Paris, , France
Institut CURIE
Paris, , France
APHP Hopital TENON
Paris, , France
Institut Jean Godinot
Reims, , France
Institut de Cancérologie de la Loire
Saint-Etienne, , France
Centre Paul Strauss
Strasbourg, , France
Institut Claudius regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Related Links
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French National Protocol Registration System
Other Identifiers
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2007-005706-44
Identifier Type: -
Identifier Source: org_study_id
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