Cancer Clinical Trial
— TOPO-LAPAOfficial 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
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 |
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Francois Baclesse | Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète, GlaxoSmithKline |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|