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Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer (TOPO-LAPA)

Primary Purpose

Cancer, Ovarian, Relapse

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
TOPOTECAN
LAPATINIB
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring ovarian - cancer - relapse - topotecan - lapatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre François Baclesse
  • Centre Paul Papin
  • CHU Jean MINJOZ
  • Institut Bergonié
  • Centre G-F Leclerc
  • CHD Les Oudairies
  • Centre Jean Bernard
  • Centre Val d'Aurelle
  • Centre azuréen de cancérologie
  • Centre Alexis vautrin
  • Centre Catherine de Sienne
  • Centre René Gauducheau
  • Centre Antoine Lacassagne
  • Hôpital Diaconesses
  • Institut CURIE
  • APHP Hopital TENON
  • Institut Jean Godinot
  • Institut de Cancérologie de la Loire
  • Centre Paul Strauss
  • Institut Claudius regaud
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.

Secondary Outcome Measures

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)

Full Information

First Posted
April 27, 2009
Last Updated
April 27, 2009
Sponsor
Centre Francois Baclesse
Collaborators
GlaxoSmithKline, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
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1. Study Identification

Unique Protocol Identification Number
NCT00888810
Brief Title
Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
lack of efficacy (intermediate analysis)
Study Start Date
March 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Francois Baclesse
Collaborators
GlaxoSmithKline, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Ovarian, Relapse, Chemotherapy
Keywords
ovarian - cancer - relapse - topotecan - lapatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TOPOTECAN
Other Intervention Name(s)
HYCAMTIN
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
LAPATINIB
Other Intervention Name(s)
TYVERB
Intervention Description
Daily oral administration during all the study. 1250 mg/day
Primary Outcome Measure Information:
Title
Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.
Time Frame
every two cycles of chemotherapy
Secondary Outcome Measure Information:
Title
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)
Time Frame
each cycle of chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence JOLY, MD-PHD
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHU Jean MINJOZ
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre G-F Leclerc
City
Dijon
ZIP/Postal Code
21076
Country
France
Facility Name
CHD Les Oudairies
City
La ROCHE SUR YON
ZIP/Postal Code
85025
Country
France
Facility Name
Centre Jean Bernard
City
Le MANS
ZIP/Postal Code
72015
Country
France
Facility Name
Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre azuréen de cancérologie
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
Centre Alexis vautrin
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hôpital Diaconesses
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Institut CURIE
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
APHP Hopital TENON
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint Etienne
ZIP/Postal Code
42271
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Claudius regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.e-cancer.fr
Description
French National Protocol Registration System

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

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