CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 513 enrolled
Drug / intervention
Cisplatin +5 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with stage IVB, recurrent, or persistent disease
  • Disease not amenable to curative surgery and/or radiotherapy
  • At least 1 unidimensionally measurable lesion (≥20 mm by conventional imaging or ≥10 mm by spiral CT)
  • Target lesion must be outside previously irradiated field
Key exclusion· 6
  • No prior chemotherapy except when concurrently administered with radiotherapy
  • No bilateral hydronephrosis unless alleviated by ureteral stents or percutaneous drainage
  • No prior or concurrent malignancy within 5 years except nonmelanoma skin cancer
  • No concurrent clinically significant infection

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

Search/NCT00064077
NCT00064077Phase 3Completed

A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix

Gynecologic Oncology Group·interventional·Posted Jul 9, 2003·Updated Oct 17, 2018

In Brief

A Phase 3 clinical trial evaluating Cisplatin, Gemcitabine Hydrochloride, and 4 other interventions for Cervical Adenocarcinoma and 4 related conditions. Completed, enrolled 513 participants across 1 site.

Detailed Summary

This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.

Study Details

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

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2003
Enrollment StartMay 1, 2003
Primary CompletionJan 1, 2011
Study CompletionJan 30, 2018
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 23.0 years ago

Interventions

Cisplatindrug

Given IV

Gemcitabine Hydrochloridedrug

Paclitaxeldrug

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Topotecan Hydrochloridedrug

Given IV

Vinorelbine Tartratedrug

Given IV