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
18 Years
N/A
Female
Endometrial Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival as measured by Kaplan Meier and RECIST at 18 months
Safety Issue:
No
Principal Investigator
Nicholas S. Reed, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Glasgow
Authority:
United States: Federal Government
Study ID:
EORTC-55984
NCT ID:
NCT00052312
Start Date:
September 2002
Completion Date:
Related Keywords:
- Endometrial Cancer
- recurrent endometrial carcinoma
- stage III endometrial carcinoma
- stage IV endometrial carcinoma
- endometrial papillary serous carcinoma
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
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