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| Sponsored by: |
National Cancer Institute of Canada |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030485 |
Purpose
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.
PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.
| Condition | Intervention | Phase |
|
Endometrial Cancer |
Drug: erlotinib hydrochloride |
Phase II |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Erlotinib Erlotinib hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are also followed every 3 months until relapse or death.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic and/or locally advanced adenocarcinoma or adenosquamous carcinoma of the endometrium
Clinically and/or radiologically documented disease with at least 1 unidimensionally measurable site
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Ophthalmic:
No significant ophthalmologic abnormalities, including any of the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Canada, Alberta | |||||
| Cross Cancer Institute | |||||
| Edmonton, Alberta, Canada, T6G 1Z2 | |||||
| Tom Baker Cancer Center - Calgary | |||||
| Calgary, Alberta, Canada, T2N 4N2 | |||||
| Canada, British Columbia | |||||
| British Columbia Cancer Agency | |||||
| Vancouver, British Columbia, Canada, V5Z 4E6 | |||||
| Canada, Ontario | |||||
| Cancer Care Ontario-London Regional Cancer Centre | |||||
| London, Ontario, Canada, N6A 4L6 | |||||
| Kingston Regional Cancer Centre | |||||
| Kingston, Ontario, Canada, K7L 5P9 | |||||
| Margaret and Charles Juravinski Cancer Centre | |||||
| Hamilton, Ontario, Canada, L8V 5C2 | |||||
| Princess Margaret Hospital | |||||
| Toronto, Ontario, Canada, M5G 2M9 | |||||
| Canada, Quebec | |||||
| Hopital Notre- Dame du CHUM | |||||
| Montreal, Quebec, Canada, H4L 2M1 | |||||
| National Cancer Institute of Canada |
| Study Chair: | Amit M. Oza, MD | Princess Margaret Hospital, Canada |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Oza AM, Eisenhauer EA, Elit L, Cutz JC, Sakurada A, Tsao MS, Hoskins PJ, Biagi J, Ghatage P, Mazurka J, Provencher D, Dore N, Dancey J, Fyles A. Phase II study of erlotinib in recurrent or metastatic endometrial cancer: NCIC IND-148. J Clin Oncol. 2008 Sep 10;26(26):4319-25. Epub 2008 Jun 30.
  |
|
Oza A, Elit L, Eisenhauer E, et al.: Phase II study of erlotinib (Tarceva, OSI 774) in women with recurrent or metastatic endometrial cancer -- NCIC IND.148. [Abstract] Clin Cancer Res 9 (Suppl): A-105, 6094s, 2003.
  |
| Study ID Numbers: | CDR0000069169, CAN-NCIC-IND148, NCI-NCIC-148 |
| First Received: | February 14, 2002 |
| Last Updated: | November 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00030485 |
| Health Authority: | United States: Federal Government |
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