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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
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 :	September 2002
Actual Primary Completion Date :	September 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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  Show 35 Study Locations

Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Study Chair:	Nicholas S. Reed, MD	University of Glasgow
Study Chair:	Giorgio Bolis, MD	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

More Information

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Responsible Party:	European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:	NCT00052312 History of Changes
Other Study ID Numbers:	EORTC-55984
First Posted:	January 27, 2003
Last Update Posted:	September 24, 2012
Last Verified:	September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:

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

Additional relevant MeSH terms:

Endometrial Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Paclitaxel; Liposomal doxorubicin; Albumin-Bound Paclitaxel; Cisplatin	Doxorubicin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors