|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027690 |
Purpose
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of endometrial cancer.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have persistent or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|
Endometrial Cancer |
Drug: gefitinib |
Phase II |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | ZD1839 |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial Of ZD 1839 (IRESSA) (NSC #715055, IND #61187) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma |
| Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 2.5-6 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary endometrial carcinoma
Received 1 prior chemotherapy regimen for endometrial carcinoma
At least 1 unidimensionally measurable lesion
Tumors within a previously irradiated field are designated as non-target lesions
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Hawaii | |||||
| MBCCOP - Hawaii | |||||
| Honolulu, Hawaii, United States, 96813 | |||||
| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| United States, New Mexico | |||||
| University of New Mexico Health Science Center | |||||
| Albuquerque, New Mexico, United States, 87131-5286 | |||||
| United States, North Carolina | |||||
| Lineberger Comprehensive Cancer Center, UNC | |||||
| Chapel Hill, North Carolina, United States, 27599-7295 | |||||
| United States, Pennsylvania | |||||
| Abington Memorial Hospital | |||||
| Abington, Pennsylvania, United States, 19001-3788 | |||||
| Fox Chase Cancer Center | |||||
| Philadelphia, Pennsylvania, United States, 19111 | |||||
| United States, Texas | |||||
| University of Texas Medical Branch | |||||
| Galveston, Texas, United States, 77555-0587 | |||||
| Norway | |||||
| Norwegian Radium Hospital | |||||
| Oslo, Norway, N-0310 | |||||
| Gynecologic Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Kimberly K. Leslie, MD | University of New Mexico |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069057, GOG-0229C |
| First Received: | December 7, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00027690 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|