Clinical trial NCT00888810: Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Ovarian
Relapse
Chemotherapy
Keywords: ovarian - cancer - relapse - topotecan - lapatinib
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
First posted: 2009-04-28
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.
timeFrame: every two cycles of chemotherapy
Secondary outcomes:
measure: 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)
timeFrame: each cycle of chemotherapy
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
state: Calvados
city: Angers
country: France
facility: Centre Paul Papin
city: Besancon
country: France
facility: CHU Jean MINJOZ
city: Bordeaux
country: France
facility: Institut Bergonié
city: Dijon
country: France
facility: Centre G-F Leclerc
city: La ROCHE SUR YON
country: France
facility: CHD Les Oudairies
city: Le MANS
country: France
facility: Centre Jean Bernard
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Mougins
country: France
facility: Centre azuréen de cancérologie
city: Nancy
country: France
facility: Centre Alexis vautrin
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nantes
country: France
facility: Centre René Gauducheau
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Diaconesses
city: Paris
country: France
facility: Institut CURIE
city: Paris
country: France
facility: APHP Hopital TENON
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Etienne
country: France
facility: Institut de Cancérologie de la Loire
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre François Baclesse
name: Florence JOLY, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References: