Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
Endometrial Cancer
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial papillary serous carcinoma
Eligibility Criteria
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
Sites / Locations
- Allgemeines Krankenhaus - Universitatskliniken
- Ziekenhuis Netwerk Antwerpen Middelheim
- Institut Jules Bordet
- Universitair Ziekenhuis Antwerpen
- Cazk Groeninghe - Campus Maria's Voorzienigheid
- U.Z. Gasthuisberg
- Algemeen Ziekenhuis Sint-Augustinus
- Centre Regional Francois Baclesse
- Centre Leon Berard
- Centro di Riferimento Oncologico - Aviano
- I.R.C.C.S. Policlinico San Matteo
- Azienda Sanitaria Ospedaliera Ordine Mauriziano
- Clinica Universitaria
- Ospedale Civile
- Onze Lieve Vrouwe Gasthuis
- Academisch Medisch Centrum at University of Amsterdam
- Medisch Spectrum Twente
- Leiden University Medical Center
- Universitair Medisch Centrum St. Radboud - Nijmegen
- University Medical Center Utrecht
- Hospitais da Universidade de Coimbra (HUC)
- Hospital Universitario San Carlos
- Hospital Universitario 12 de Octubre
- Instituto Valenciano De Oncologia
- Royal United Hospital
- Bristol Haematology and Oncology Centre
- Leeds Cancer Centre at St. James's University Hospital
- Clatterbridge Centre for Oncology NHS Trust
- James Cook University Hospital
- Northern Centre for Cancer Treatment at Newcastle General Hospital
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Nottingham City Hospital NHS Trust
- Oldchurch Hospital
- Centre for Cancer Research and Cell Biology at Belfast City Hospital
- Western Infirmary