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

First listed
Apr 28, 2009
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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