Overview

Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Doxorubicin
Liposomal doxorubicin
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