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:

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

Tracking Information

First Received Date ^ICMJE

April 27, 2009

Last Updated Date

April 27, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer
Ovarian
Relapse
Chemotherapy

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00888810

Other Study ID Numbers ^ICMJE

2007-005706-44

Has Data Monitoring Committee

Yes

Responsible Party

Pr Florence JOLY - MD-PHD, Centre François Baclesse

Study Sponsor ^ICMJE

Centre Francois Baclesse

Collaborators ^ICMJE

GlaxoSmithKline
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Investigators ^ICMJE

Principal Investigator:

Florence JOLY, MD-PHD

Centre François Baclesse

Information Provided By

Centre Francois Baclesse

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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