CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 571 enrolled
Drug / intervention
carboplatin +1 moredrug
Likely dose
Carboplatin AUC 6 and Paclitaxel 175 mg/m² every 21 days for 3 courses, followed by either low-dose Paclitaxel 40 mg/m² weekly or observationAI-extracted
Key inclusion· 9
  • Histologically confirmed ovarian epithelial cancer of one of the specified cell types (serous, Brenner, mucinous, endometrioid, clear cell, undifferentiated, transitional cell, mixed epithelial, or NOS adenocarcinoma)
  • Stage Ia or Ib grade 3 or clear cell, OR Stage Ic or II any grade/histology
  • Complete surgical staging performed
  • WBC at least 3,000/mm³
Key exclusion· 5
  • Tumors of low malignant potential (borderline tumors)
  • Other invasive malignancies within the past 5 years except nonmelanoma skin cancer
  • Major systemic medical illness expected to affect survival
  • Body surface area greater than 2.0 m²

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

Search/NCT00003644
NCT00003644Phase 3Completed

A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma

Gynecologic Oncology Group·interventional·Posted Jan 27, 2003·Updated Jun 4, 2019

In Brief

A Phase 3 clinical trial evaluating carboplatin and paclitaxel for Ovarian Cancer. Completed, enrolled 571 participants across 151 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesJapan, United States

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartOct 1, 1998
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11.4 yearsPosted 23.4 years ago

Interventions

carboplatindrug

paclitaxeldrug