Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer (TOPO-LAPA)
This study has been terminated.
(lack of efficacy (intermediate analysis))
Sponsor:
Centre Francois Baclesse
Collaborators:
GlaxoSmithKline
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT00888810
First received: April 27, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Ovarian Relapse Chemotherapy |
Drug: TOPOTECAN Drug: LAPATINIB |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Centre Francois Baclesse:
Primary Outcome Measures:
- Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib. [ Time Frame: every two cycles of chemotherapy ] [ Designated as safety issue: Yes ]
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) [ Time Frame: each cycle of chemotherapy ] [ Designated as safety issue: Yes ]
| Enrollment: | 39 |
| Study Start Date: | March 2008 |
Intervention Details:
-
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)
Other Name: HYCAMTIN
Drug: LAPATINIB
Daily oral administration during all the study. 1250 mg/day
Other Name: TYVERB
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888810
Locations
| France | |
| Centre François Baclesse | |
| Caen, Calvados, France, 14076 | |
| Centre Paul Papin | |
| Angers, France, 49933 | |
| CHU Jean MINJOZ | |
| Besancon, France, 25030 | |
| Institut Bergonié | |
| Bordeaux, France, 33076 | |
| Centre G-F Leclerc | |
| Dijon, France, 21076 | |
| CHD Les Oudairies | |
| La ROCHE SUR YON, France, 85025 | |
| Centre Jean Bernard | |
| Le MANS, France, 72015 | |
| Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Centre azuréen de cancérologie | |
| Mougins, France, 06250 | |
| Centre Alexis vautrin | |
| Nancy, France, 54511 | |
| Centre René Gauducheau | |
| Nantes, France, 44805 | |
| Centre Catherine de Sienne | |
| Nantes, France, 44202 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| APHP Hopital TENON | |
| Paris, France, 75970 | |
| Institut CURIE | |
| Paris, France, 75231 | |
| Hôpital Diaconesses | |
| Paris, France, 75012 | |
| Institut Jean Godinot | |
| Reims, France, 51056 | |
| Institut de Cancérologie de la Loire | |
| Saint Etienne, France, 42271 | |
| Centre Paul Strauss | |
| Strasbourg, France, 67065 | |
| Institut Claudius regaud | |
| Toulouse, France, 31052 | |
| Institut Gustave Roussy | |
| Villejuif, France, 94805 | |
Sponsors and Collaborators
Centre Francois Baclesse
GlaxoSmithKline
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Investigators
| Principal Investigator: | Florence JOLY, MD-PHD | Centre François Baclesse |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pr Florence JOLY - MD-PHD, Centre François Baclesse |
| ClinicalTrials.gov Identifier: | NCT00888810 History of Changes |
| Other Study ID Numbers: | 2007-005706-44 |
| Study First Received: | April 27, 2009 |
| Last Updated: | April 27, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Francois Baclesse:
|
ovarian - cancer - relapse - topotecan - lapatinib |
Additional relevant MeSH terms:
|
Topotecan Lapatinib Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013