Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer

Phase 2

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT00052312
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy work in 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 doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer.

Detailed Description

OBJECTIVES:

* Compare the overall survival of patients with locally advanced, metastatic, and/or relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel.

* Compare the toxicity of these regimens in these patients.

* Compare the progression-free survival at 18 months of patients treated with these regimens.

* Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (0 vs 1 vs 2), metastatic disease (M0 vs M1), prior pelvic radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive doxorubicin IV over 30 minutes, paclitaxel IV over 3 hours, and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients receive doxorubicin and cisplatin as in arm I. Quality of life is assessed at baseline, before each course, after courses 3 and 6, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, quality of life is assessed every 3 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-01-24
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival as measured by Kaplan Meier and RECIST at 18 months

Secondary Outcome Measures

Name	Time	Method
Overall survival as measured by Kaplan Meier after each course, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course

Trial Locations

Locations (35)

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Instituto Valenciano De Oncologia; 🇪🇸 Valencia, Spain

Cazk Groeninghe - Campus Maria's Voorzienigheid; 🇧🇪 Kortrijk, Belgium

I.R.C.C.S. Policlinico San Matteo; 🇮🇹 Pavia, Italy

Academisch Medisch Centrum at University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Azienda Sanitaria Ospedaliera Ordine Mauriziano; 🇮🇹 Turin, Italy

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen; 🇳🇱 Nijmegen, Netherlands

Allgemeines Krankenhaus - Universitatskliniken; 🇦🇹 Vienna, Austria

Ziekenhuis Netwerk Antwerpen Middelheim; 🇧🇪 Antwerp, Belgium

Algemeen Ziekenhuis Sint-Augustinus; 🇧🇪 Wilrijk, Belgium

Hospital Universitario San Carlos; 🇪🇸 Madrid, Spain

Centre Leon Berard; 🇫🇷 Lyon, France

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Centro di Riferimento Oncologico - Aviano; 🇮🇹 Aviano, Italy

Clinica Universitaria; 🇮🇹 Turin, Italy

Ospedale Civile; 🇮🇹 Voghera, Italy

Clatterbridge Centre for Oncology NHS Trust; 🇬🇧 Merseyside, England, United Kingdom

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

Mount Vernon Cancer Centre at Mount Vernon Hospital; 🇬🇧 Northwood, England, United Kingdom

Northern Centre for Cancer Treatment at Newcastle General Hospital; 🇬🇧 Newcastle-Upon-Tyne, England, United Kingdom

Centre for Cancer Research and Cell Biology at Belfast City Hospital; 🇬🇧 Belfast, Northern Ireland, United Kingdom

Hospitais da Universidade de Coimbra (HUC); 🇵🇹 Coimbra, Portugal

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

James Cook University Hospital; 🇬🇧 Middlesbrough, England, United Kingdom

Royal United Hospital; 🇬🇧 Bath, England, United Kingdom

Nottingham City Hospital NHS Trust; 🇬🇧 Nottingham, England, United Kingdom

Oldchurch Hospital; 🇬🇧 Romford, England, United Kingdom

Western Infirmary; 🇬🇧 Glasgow, Scotland, United Kingdom

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands