Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: pegylated liposomal doxorubicin hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00005861

CDR0000067891

GOG-0086M

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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