Cancer, Chemotherapy, Ovarian, Relapse
Conditions
Keywords
ovarian - cancer - relapse - topotecan - lapatinib
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.
Interventions
DRUGTOPOTECAN
IV administration on Day 1, day 8 and day 15, at the dose level of 3.2 mg/m² for 6 cycles of 28 days(up to 8 cycles)
DRUGLAPATINIB
Daily oral administration during all the study. 1250 mg/day
Sponsors
GlaxoSmithKline
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Centre Francois Baclesse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib. | every two cycles of chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed