Status:
TERMINATED
Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
GlaxoSmithKline
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Conditions:
Cancer
Ovarian
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00888810
Start Date
March 1 2008
Last Update
April 28 2009
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre François Baclesse
Caen, CALVADOS, France, 14076
2
Centre Paul Papin
Angers, France, 49933
3
CHU Jean MINJOZ
Besançon, France, 25030
4
Institut Bergonié
Bordeaux, France, 33076