Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer
- Conditions
- CancerOvarianRelapseChemotherapy
- Registration Number
- NCT00888810
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 39
- 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
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib. every two cycles of chemotherapy
- Secondary Outcome Measures
Name Time Method 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) each cycle of chemotherapy
Trial Locations
- Locations (21)
Centre François Baclesse
🇫🇷Caen, Calvados, France
Centre G-F Leclerc
🇫🇷Dijon, France
Institut Bergonié
🇫🇷Bordeaux, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Centre René Gauducheau
🇫🇷Nantes, France
Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Jean Bernard
🇫🇷Le MANS, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Claudius regaud
🇫🇷Toulouse, France
Centre Paul Papin
🇫🇷Angers, France
CHU Jean MINJOZ
🇫🇷Besancon, France
CHD Les Oudairies
🇫🇷La ROCHE SUR YON, France
Centre Alexis vautrin
🇫🇷Nancy, France
Centre azuréen de cancérologie
🇫🇷Mougins, France
Hôpital Diaconesses
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Institut de Cancérologie de la Loire
🇫🇷Saint Etienne, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Institut CURIE
🇫🇷Paris, France
APHP Hopital TENON
🇫🇷Paris, France