CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
imatinib mesylate +1 moredrug
Likely dose
Imatinib mesylate orally (dose not specified in eligibility or arms section)AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed uterine carcinosarcoma (malignant mixed Mullerian tumor, homologous or heterologous type) that is persistent or recurrent with documented disease progression after appropriate local therapy
  • ✓At least one measurable lesion (≥20 mm by conventional imaging or ≥10 mm by spiral CT) and at least one RECIST-defined target lesion
  • ✓Exactly one prior chemotherapy regimen for carcinosarcoma management (may include high-dose, consolidation, or extended therapy)
  • ✓Performance status: GOG 0–1 if 2 prior regimens; GOG 0–2 if 1 prior regimen
Key exclusion· 10
  • ✕Previous treatment with Gleevec (imatinib mesylate)
  • ✕Other invasive malignancies within 5 years, except non-melanoma skin cancer
  • ✕Signs or symptoms of bowel dysfunction or obstruction
  • ✕Therapeutic anticoagulation with warfarin

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

Search/NCT00075400
NCT00075400Phase 2Completed
CompareCT.gov

A Phase II Evaluation of Gleevec(TM) (NCI-Supplied Agent: STI571 [Imatinib Mesylate], NSC# 716051) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

National Cancer Institute (NCI)·interventional·Posted Jan 12, 2004·Updated Jul 24, 2019

In Brief

A Phase 2 clinical trial evaluating imatinib mesylate and laboratory biomarker analysis for Recurrent Uterine Sarcoma and Uterine Carcinosarcoma. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This phase II clinical trial studies the side effects and how well imatinib mesylate works in treating patients with uterine cancer that has failed to respond to initial chemotherapy or has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Uterine Sarcoma, Uterine Carcinosarcoma
CountriesUnited States
CollaboratorsGynecologic Oncology Group

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 12, 2004
Enrollment StartJan 1, 2004
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 22.5 years ago

Interventions

imatinib mesylatedrug

Given PO

laboratory biomarker analysisother

Correlative studies