Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

Basic Trial Information

Objectives

I. Assess the antitumor activity of danazol in patients with advanced or 
recurrent endometrial cancer.

II. Determine the nature and toxicity of danazol in these patients.  

Entry Criteria

Disease Characteristics:

Histologically proven advanced or recurrent endometrial cancer that is not
 amenable to curative surgery or radiotherapy

Measurable disease
 Tumor at least 1.0 cm by 1.0 cm per x-ray or physical exam OR
 Tumor at least 2.0 cm by 2.0 cm per CT scan, MRI, or ultrasound 

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 At least 3 weeks since prior radiotherapy and recovered

Surgery:
 At least 3 weeks since prior surgery and recovered 
 

Patient Characteristics:

Age:
 Not specified

Performance status:
 GOG 0-2

Life expectancy:
 Not specified

Hematopoietic:
 WBC at least 3000/mm3
 Platelet count at least 100,000/mm3
 No history of porphyria

Hepatic:
 Bilirubin no greater than 1.5 times normal
 SGOT no greater than 3 times normal
 Alkaline phosphatase no greater than 3 times normal

Renal:
 Creatinine no greater than 2 mg/dL

Other:
 No concurrent or prior malignancy within past 5 years (except nonmelanoma
  skin cancer) or for which patient received chemotherapy
 Not pregnant or nursing
 Fertile patients must use effective contraception
 Must have tissue available for estrogen receptor/ progesterone receptor
  analysis

Expected Enrollment

A total of 23-56 patients will be accrued for this study within 26 months.   

Outline

Patients receive oral danazol 4 times per day for at least 4 weeks.  Patients 
with partial response, complete response, or stable disease continue treatment 
in the absence of disease progression or unacceptable toxicity.  

Patients are followed every 3 months for 2 years, every 6 months for 2 years, 
and then annually thereafter.   

Covens A, Brunetto VL, Markman M, et al.: Phase II trial of danazol in advanced, recurrent, or persistent endometrial cancer: a Gynecologic Oncology Group study. Gynecol Oncol 89 (3): 470-4, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Allan Covens, MD, Protocol chair		Ph: 416-480-4026 Email: al.covens@sunnybrook.ca

Registry Information
Official Title		Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer
Trial Start Date		1999-08-09
Registered in ClinicalTrials.gov		NCT00003946
Date Submitted to PDQ		1999-06-18
Information Last Verified		2004-07-16

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