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Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

Phase 2
21 Years
Not Enrolling
Endometrial Cancer, Sarcoma

Thank you

Trial Information

Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

OBJECTIVES: I. Estimate the antitumor activity of doxorubicin HCl liposome in patients with
recurrent or advanced uterine sarcoma. II. Determine the nature and degree of toxicity of
this drug in this patient population.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Treatment continues every
4 weeks in the absence of unacceptable toxicity or disease progression. Patients are
followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1-1.5

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent or recurrent
uterine sarcoma with documented disease progression after appropriate local therapy
Leiomyosarcoma Malignant mixed mullerian tumor (mixed mesodermal tumor, mixed heterologous
mesenchymal sarcoma) Mixed malignant Muellerian tumor (carcinosarcoma, homologous
mesenchymal sarcoma) Endometrial stromal sarcoma Other uterine sarcomas Considered
incurable Bidimensionally measurable disease consisting of abdominal, pelvic, chest, or
other masses by palpation, x-ray, computed tomography, or ultrasound

PATIENT CHARACTERISTICS: Age: Over 21 Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 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 mg/dL Cardiovascular: LVEF normal by MUGA scan Other: No
clinically significant infection No other malignancy within the past 5 years except
nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior therapy
with cytotoxic drugs No prior doxorubicin HCl liposome No prior doxorubicin greater than
360 mg/m2 No other concurrent antineoplastic agents Endocrine therapy: Not specified
Radiotherapy: Recovered from prior radiotherapy No prior radiotherapy for any other
malignancy Surgery: Recovered from prior surgery Other: No other concurrent
investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gregory P. Sutton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • uterine carcinosarcoma
  • uterine leiomyosarcoma
  • endometrial stromal sarcoma
  • Endometrial Neoplasms
  • Leiomyosarcoma
  • Adenoma
  • Sarcoma



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