CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
lapatinib ditosylate +1 moredrug
Likely dose
Lapatinib ditosylate orally (specific dose not stated in provided text)AI-extracted
Key inclusion· 5
  • ✓Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal cancer
  • ✓At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • ✓Disease progression during OR persistent disease after 1 prior platinum-based chemotherapy regimen with treatment-free interval < 12 months
  • ✓Tumor accessible by guided core needle or fine needle biopsy
Key exclusion· 7
  • ✕Prior trastuzumab or cetuximab
  • ✕Prior non-cytotoxic chemotherapy for recurrent or persistent disease
  • ✕Other invasive malignancy within past 5 years except nonmelanoma skin cancer
  • ✕Sensory or motor neuropathy > grade 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00113373
NCT00113373Phase 2Completed
CompareCT.gov

A Phase II Evaluation of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

National Cancer Institute (NCI)·interventional·Posted Jun 8, 2005·Updated Jul 24, 2019

In Brief

A Phase 2 clinical trial evaluating lapatinib ditosylate and laboratory biomarker analysis for Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer. Completed, enrolled 28 participants across 1 site.

Detailed Summary

Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
CountriesUnited States
CollaboratorsGynecologic Oncology Group

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2005
Enrollment StartMay 1, 2005
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 21.1 years ago

Interventions

lapatinib ditosylatedrug

Given orally

laboratory biomarker analysisother

Correlative studies