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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

April 27, 2009
April 27, 2009
March 2008
Not Provided
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Ovarian
  • Relapse
  • Chemotherapy
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
39
Not Provided
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00888810
2007-005706-44
Yes
Pr Florence JOLY - MD-PHD, Centre François Baclesse
Centre Francois Baclesse
  • GlaxoSmithKline
  • Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Principal Investigator: Florence JOLY, MD-PHD Centre François Baclesse
Centre Francois Baclesse
April 2009

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