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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00888810
Other study ID # 2007-005706-44
Secondary ID
Status Terminated
Phase Phase 2
First received April 27, 2009
Last updated April 27, 2009
Start date March 2008

Study information

Verified date April 2009
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 39
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
TOPOTECAN
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)
LAPATINIB
Daily oral administration during all the study. 1250 mg/day

Locations

Country Name City State
France Centre Paul Papin Angers
France CHU Jean MINJOZ Besancon
France Institut Bergonié Bordeaux
France Centre François Baclesse Caen Calvados
France Centre G-F Leclerc Dijon
France CHD Les Oudairies La ROCHE SUR YON
France Centre Jean Bernard Le MANS
France Centre Val d'Aurelle Montpellier
France Centre azuréen de cancérologie Mougins
France Centre Alexis vautrin Nancy
France Centre Catherine de Sienne Nantes
France Centre René Gauducheau Nantes
France Centre Antoine Lacassagne Nice
France APHP Hopital TENON Paris
France Hôpital Diaconesses Paris
France Institut CURIE Paris
France Institut Jean Godinot Reims
France Institut de Cancérologie de la Loire Saint Etienne
France Centre Paul Strauss Strasbourg
France Institut Claudius regaud Toulouse
France Institut Gustave Roussy Villejuif

Sponsors (3)

Lead Sponsor Collaborator
Centre Francois Baclesse Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète, GlaxoSmithKline

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib. every two cycles of chemotherapy Yes
Secondary 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 Yes
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