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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Francois Baclesse
• Collaborators: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète; Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète; GlaxoSmithKline
• Treatments: Lapatinib; Topotecan

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