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

NCT00052312 | Completed Phase 2

• 1 other identifier: EORTC-55984
• Study Type: interventional
• Target: 141
• Locations: 8 countries
• Sites: 35

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.

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma; endometrial papillary serous carcinoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

cisplatin DRUG

doxorubicin hydrochloride DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (35)

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

Location

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Sanitaria Ospedaliera Ordine Mauriziano

Turin, 10128, Italy

Location

Clinica Universitaria

Turin, 10138, Italy

Location

Ospedale Civile

Voghera, 27058, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Belfast City Hospital

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Cisplatin; Doxorubicin; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Nicholas S. Reed, MD

  University of Glasgow

  STUDY CHAIR

• Giorgio Bolis, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: September 1, 2006
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

PT (1); BE (6); NL (6); IT (5); GB (11); ES (3); AU (1); FR (2)