CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Paclitaxel +4 moredrug
Likely dose
Paclitaxel 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00515073
NCT00515073Phase 2Completed

A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium

M.D. Anderson Cancer Center·interventional·Posted Aug 13, 2007·Updated Jul 3, 2014

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Pelvic Radiation, and 3 other interventions for Endometrial Cancer. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

Primary Objectives: * To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary serous carcinoma of the endometrium for both local control and overall survival. * To evaluate the toxicity of Paclitaxel and pelvic radiation. * To collect and evaluate patients' quality of life/symptom assessment data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 13, 2007
Enrollment StartApr 1, 2001
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 12.1 yearsPosted 18.9 years ago

Interventions

Paclitaxeldrug

50 mg/m\^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m\^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.

Pelvic Radiationradiation

Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.

Dexamethasonedrug

20 mg IV given 30 minutes prior to chemotherapy

Cimetidinedrug

300 mg IV given 30 minutes prior to chemotherapy

Diphenhydraminedrug

50 mg IV given 30 minutes prior to chemotherapy