CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,312 enrolled
Drug / intervention
Paclitaxel +5 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal serous carcinoma
  • Optimal (≤1 cm residual) or suboptimal residual disease after initial surgery
  • GOG performance status 0-2
  • Prior borderline ovarian tumor allowed if no prior chemotherapy
Key exclusion· 10
  • Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, or mixed Müllerian tumors
  • Low malignant potential tumors including micropapillary serous carcinomas
  • Mucinous primary peritoneal carcinoma
  • Metastatic carcinomas from other sites to the ovary

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

Search/NCT00011986
NCT00011986Phase 3Completed

A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma

Gynecologic Oncology Group·interventional·Posted Jan 27, 2003·Updated Apr 16, 2019

In Brief

A Phase 3 clinical trial evaluating Paclitaxel, Carboplatin, and 4 other interventions for Primary Peritoneal Carcinoma and 2 related conditions. Completed, enrolled 4,312 participants across 1 site.

Detailed Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.

Study Details

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

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJan 1, 2001
Primary CompletionMar 1, 2010
Study CompletionJan 28, 2013
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 23.4 years ago

Interventions

Paclitaxeldrug

Given IV

Carboplatindrug

Given IV

Gemcitabine Hydrochloridedrug

Given IV

Pegylated Liposomal Doxorubicin Hydrochloridedrug

Topotecan Hydrochloridedrug

Given IV

Therapeutic Conventional Surgeryprocedure

Undergo surgery