CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Gemcitabine Hydrochloride +1 moredrug
Likely dose
Gemcitabine and docetaxel (IV); specific doses not stated in interventionsAI-extracted
Key inclusion· 9
  • ✓Histologically confirmed uterine carcinosarcoma (malignant mixed Müllerian tumor) with recurrent or persistent disease after prior local therapy
  • ✓Measurable disease: ≥1 lesion ≥20 mm by conventional imaging OR ≥10 mm by spiral CT, with at least 1 target lesion
  • ✓Exactly one prior chemotherapy regimen for carcinosarcoma
  • ✓GOG performance status 0–2
Key exclusion· 6
  • ✕Active infection requiring antibiotics
  • ✕Severe pulmonary disease requiring oxygen supplementation
  • ✕Pregnant or nursing
  • ✕Other invasive malignancy within past 5 years (except nonmelanoma skin cancer)

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

Search/NCT00114218
NCT00114218Phase 2Completed
CompareCT.gov

A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel (NSC # 628503) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Gynecologic Oncology Group·interventional·Posted Jun 14, 2005·Updated Jan 8, 2019

In Brief

A Phase 2 clinical trial evaluating Gemcitabine Hydrochloride and Docetaxel for Recurrent Uterine Corpus Sarcoma and Uterine Carcinosarcoma. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 14, 2005
Enrollment StartMar 1, 2005
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 21.1 years ago

Interventions

Gemcitabine Hydrochloridedrug

Given IV

Docetaxeldrug

Given IV