Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	EORTC-55984 NCT00052312

Objectives

1. Compare the overall survival of patients with locally advanced, metastatic, and/or relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel.
2. Compare the toxicity of these regimens in these patients.
3. Compare the progression-free survival at 18 months of patients treated with these regimens.
4. Compare quality of life of patients treated with these regimens.

Entry 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

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/m²
• Total dose of prior epirubicin no greater than 300 mg/m²

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

Patient Characteristics:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count greater than 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 140 patients will be accrued for this study.

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Nicholas Reed, MD, Study coordinator(Contact information may not be current)		Ph: 44-141-211-2123 Email: nick.reed@northglasgow.scot.nhs.uk
Giorgio Bolis, MD, Study coordinator		Ph: 39-02-239-0507

Registry Information
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
Trial Start Date		2002-09-25
Registered in ClinicalTrials.gov		NCT00052312
Date Submitted to PDQ		2002-09-24
Information Last Verified		2006-11-19

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