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

Cancer Clinical Trial

— TOPO-LAPA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00888810
• Other study ID #: 2007-005706-44
• 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
• 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

• Cancer
• Chemotherapy
• Ovarian
• Relapse

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

External Links

•   French National Protocol Registration System