Endometrial Cancer
Conditions
Keywords
stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV endometrial cancer.
Detailed description
OBJECTIVES: * Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer. * Determine the response rate, response duration, and overall survival of these patients treated with this regimen. OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study.
Interventions
DRUGpegylated liposomal doxorubicin hydrochloride
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage III, IV, or recurrent endometrial carcinoma for which curative radiotherapy or surgery is not an option * Bidimensionally measurable disease * Irradiated field as only site allowed if evidence of progression since radiotherapy PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 3 times ULN * Alkaline phosphatase no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * LVEF normal by cardiac echocardiogram or MUGA Other: * No concurrent active infection * No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy as radiosensitizer allowed * No prior chemotherapy for advanced or metastatic disease * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * Recovered from prior radiotherapy Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * No prior therapy that would preclude study * No other concurrent antineoplastic agents * No other concurrent investigational agents
Countries
United States
Outcome results
None listed