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Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard D. Homesley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology Network

Authority:

United States: Federal Government

Study ID:

CDR0000067891

NCT ID:

NCT00005861

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
New England Medical Center HospitalBoston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009