Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003946
First received: November 1, 1999
Last updated: June 7, 2013
Last verified: July 2004
  Purpose

RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer.

PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: danazol
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: August 1999
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.

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.

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003946

  Show 73 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Allan Covens, MD Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003946     History of Changes
Other Study ID Numbers: CDR0000067139, GOG-0180
Study First Received: November 1, 1999
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage IV endometrial carcinoma
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Danazol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014