AzTrials
AzTrials

Endometrial CancerPhase 2NCT00052312

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

A Phase 2 study testing cisplatin, doxorubicin hydrochloride and paclitaxel in people with Endometrial Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 35 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
cisplatin, doxorubicin hydrochloride and paclitaxel
How many people
141 participants
Where
35 sitesin 8 countries
Study dates
Sep 2002to Sep 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

35 sites in 8 countries.

35 sites in 8 countries

United Kingdom11 sites

  • Royal United Hospital

    Bath, England, BA1 3NG

  • Centre for Cancer Research and Cell Biology at Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Western Infirmary

    Glasgow, Scotland, G11 6NT

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Oldchurch Hospital

    Romford, England, RM7 OBE

Other trials in United Kingdom

Belgium6 sites

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Cazk Groeninghe - Campus Maria's Voorzienigheid

    Kortrijk, B-8500

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Algemeen Ziekenhuis Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Netherlands6 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, 6500 HB

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Italy5 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • I.R.C.C.S. Policlinico San Matteo

    Pavia, 27100

  • Azienda Sanitaria Ospedaliera Ordine Mauriziano

    Turin, 10128

  • Clinica Universitaria

    Turin, 10138

  • Ospedale Civile

    Voghera, 27058

Other trials in Italy

Spain3 sites

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Instituto Valenciano De Oncologia

    Valencia, 46009

Other trials in Spain

France2 sites

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Leon Berard

    Lyon, 69373

Other trials in France

Austria1 site

  • Allgemeines Krankenhaus - Universitatskliniken

    Vienna, A-1090

Other trials in Austria

Portugal1 site

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3049

Other trials in Portugal

About this study

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

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.

Read the 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.

Keywords
recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial papillary serous carcinoma
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival as measured by Kaplan Meier and RECIST at 18 months

Secondary outcomes (2)

  1. 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

  2. Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2002
  3. Primary completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052312
Sponsor's protocol ID
EORTC-55984
Other IDs
EORTC-55984
Status last verified
Sep 2012
First submitted
24 Jan 2003
Last updated
24 Sep 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, doxorubicin hydrochloride and paclitaxel in people with Endometrial Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 35 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United Kingdom, Belgium, Netherlands, Italy, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival as measured by Kaplan Meier and RECIST at 18 months. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00052312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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