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

Sponsor
Centre Francois Baclesse
Study ID
NCT00888810
Phase
PHASE2
Status
Terminated

Conditions

  • Cancer
  • Chemotherapy
  • Ovarian
  • Relapse

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TOPOTECAN — DRUG
    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)
  • LAPATINIB — DRUG
    Daily oral administration during all the study. 1250 mg/day

Study Details

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.

Key Dates

Start date
Mar 31, 2008
Status verified
Apr 2009

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib. [ Time Frame: every two cycles of chemotherapy ]

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