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
- 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
- association in first line with other anticancer agent is allowed (taxanes,
anthracyclines, alkylants or gemcitabine) and with an anti-angiogenic (bevacizumab,
- 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