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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00052312

Collaborator

(none)

141

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

141 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allgemeines Krankenhaus - Universitatskliniken	Vienna		Austria	A-1090
2	Ziekenhuis Netwerk Antwerpen Middelheim	Antwerp		Belgium	2020
3	Institut Jules Bordet	Brussels		Belgium	1000
4	Universitair Ziekenhuis Antwerpen	Edegem		Belgium	B-2650
5	Cazk Groeninghe - Campus Maria's Voorzienigheid	Kortrijk		Belgium	B-8500
6	U.Z. Gasthuisberg	Leuven		Belgium	B-3000
7	Algemeen Ziekenhuis Sint-Augustinus	Wilrijk		Belgium	2610
8	Centre Regional Francois Baclesse	Caen		France	14076
9	Centre Leon Berard	Lyon		France	69373
10	Centro di Riferimento Oncologico - Aviano	Aviano		Italy	33081
11	I.R.C.C.S. Policlinico San Matteo	Pavia		Italy	27100
12	Azienda Sanitaria Ospedaliera Ordine Mauriziano	Turin		Italy	10128
13	Clinica Universitaria	Turin		Italy	10138
14	Ospedale Civile	Voghera		Italy	27058
15	Onze Lieve Vrouwe Gasthuis	Amsterdam		Netherlands	1091 HA
16	Academisch Medisch Centrum at University of Amsterdam	Amsterdam		Netherlands	1105 AZ
17	Medisch Spectrum Twente	Enschede		Netherlands	7500 KA
18	Leiden University Medical Center	Leiden		Netherlands	2300 CA
19	Universitair Medisch Centrum St. Radboud - Nijmegen	Nijmegen		Netherlands	6500 HB
20	University Medical Center Utrecht	Utrecht		Netherlands	3584 CX
21	Hospitais da Universidade de Coimbra (HUC)	Coimbra		Portugal	3049
22	Hospital Universitario San Carlos	Madrid		Spain	28040
23	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
24	Instituto Valenciano De Oncologia	Valencia		Spain	46009
25	Royal United Hospital	Bath	England	United Kingdom	BA1 3NG
26	Bristol Haematology and Oncology Centre	Bristol	England	United Kingdom	BS2 8ED
27	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
28	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England	United Kingdom	CH63 4JY
29	James Cook University Hospital	Middlesbrough	England	United Kingdom	TS4 3BW
30	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England	United Kingdom	NE4 6BE
31	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England	United Kingdom	HA6 2RN
32	Nottingham City Hospital NHS Trust	Nottingham	England	United Kingdom	NG5 1PB
33	Oldchurch Hospital	Romford	England	United Kingdom	RM7 OBE
34	Centre for Cancer Research and Cell Biology at Belfast City Hospital	Belfast	Northern Ireland	United Kingdom	BT9 7AB
35	Western Infirmary	Glasgow	Scotland	United Kingdom	G11 6NT