Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer

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

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.

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