CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Thalidomide +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed uterine carcinosarcoma (malignant mixed müllerian tumor), homologous or heterologous type
  • ✓Recurrent or persistent disease with documented progression after prior local therapy
  • ✓At least 1 measurable target lesion (≥20 mm by conventional imaging or ≥10 mm by spiral CT)
  • ✓Must have received 1 prior chemotherapy regimen (including high-dose consolidation or extended therapy)
Key exclusion· 8
  • ✕Prior thalidomide therapy
  • ✕Active infection requiring antibiotics
  • ✕Sensory or motor neuropathy greater than grade 1
  • ✕Other invasive malignancy within past 5 years (except nonmelanoma skin cancer)

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

Search/NCT00025506
NCT00025506Phase 2Completed
CompareCT.gov

A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated Jul 24, 2019

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis and Thalidomide for Recurrent Uterine Corpus Sarcoma and Uterine Carcinosarcoma. Completed, enrolled 55 participants across 1 site.

Detailed Summary

This phase II trial is studying how well thalidomide works in treating patients with carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or disappear but may still be in the body) despite treatment. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

Study Details

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

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 2001
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11.3 yearsPosted 23.4 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Thalidomidedrug

Given orally