Trial | NCT00888810  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    39
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.
Study Started
Mar 31
2008
Last Update
Apr 28
2009
Estimate

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 names: HYCAMTIN

Drug LAPATINIB

Daily oral administration during all the study. 1250 mg/day

  • Other names: TYVERB

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
No Results Posted