Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer

Gynecologic Oncology Group

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Endometrial Cancer

Interventions

pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (10)

Chao Family Comprehensive Cancer Center

Orange, California, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Data from ClinicalTrials.gov

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