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

Endometrial Cancer Clinical Trial

Official title:

Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00052312
• Other study ID #: EORTC-55984
• Secondary ID: EORTC-55984
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2003
• Last updated: September 20, 2012
• Start date: September 2002

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed endometrial epithelial carcinoma meeting at least 1 of the following criteria:

• Advanced metastatic and/or relapsed disease

• Locally advanced inoperable or unresectable disease

• No mixed mesodermal tumor and/or tumors showing evidence of sarcomatous elements

• Uterine papillary serous carcinoma allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count greater than 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin greater than 10 g/dL (transfusions allowed)

Hepatic

• ALT and AST less than 2 times upper limit of normal (ULN)

• Alkaline phosphatase less than 2 times ULN

• Bilirubin less than 1.5 times ULN

Renal

• Creatinine less than 1.5 times ULN

• Creatinine clearance greater than 50 mL/min

Cardiovascular

• Normal baseline EKG

• Normal baseline LVEF on MUGA or echocardiogram for patients who received prior anthracyclines

Other

• Able to tolerate high-dose dexamethasone

• Must be considered fit for chemotherapy

• No uncontrolled infection

• No other malignancy within the past 5 years except successfully treated basal cell skin cancer or carcinoma in situ of the cervix

• No prior nervous or psychiatric disorder that would preclude study compliance

• No psychological, familial, sociological, or geographic condition that would preclude study participation

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 12 months since prior adjuvant chemotherapy

• Total dose of prior doxorubicin no greater than 200 mg/m^2

• Total dose of prior epirubicin no greater than 300 mg/m^2

Endocrine therapy

• At least 28 days since prior hormonal therapy for patients with partial or complete response after first-line treatment

Radiotherapy

• No prior radiotherapy to any area other than pelvis

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No other concurrent anticancer medications

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• cisplatin

• doxorubicin hydrochloride

• paclitaxel

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus - Universitatskliniken	Vienna
Belgium	Ziekenhuis Netwerk Antwerpen Middelheim	Antwerp
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Cazk Groeninghe - Campus Maria's Voorzienigheid	Kortrijk
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	Algemeen Ziekenhuis Sint-Augustinus	Wilrijk
France	Centre Regional Francois Baclesse	Caen
France	Centre Leon Berard	Lyon
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	I.R.C.C.S. Policlinico San Matteo	Pavia
Italy	Azienda Sanitaria Ospedaliera Ordine Mauriziano	Turin
Italy	Clinica Universitaria	Turin
Italy	Ospedale Civile	Voghera
Netherlands	Academisch Medisch Centrum at University of Amsterdam	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Universitair Medisch Centrum St. Radboud - Nijmegen	Nijmegen
Netherlands	University Medical Center Utrecht	Utrecht
Portugal	Hospitais da Universidade de Coimbra (HUC)	Coimbra
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario San Carlos	Madrid
Spain	Instituto Valenciano De Oncologia	Valencia
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Centre for Cancer Research and Cell Biology at Belfast City Hospital	Belfast	Northern Ireland
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Western Infirmary	Glasgow	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Oldchurch Hospital	Romford	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Italy,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival as measured by Kaplan Meier and RECIST at 18 months			No
Secondary	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			No
Secondary	Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course			Yes