Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Nicholas S. Reed

Giorgio Bolis

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00052312
Information obtained from ClinicalTrials.gov on December 19, 2011

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