Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00030485|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 27, 2014
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 or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: erlotinib hydrochloride||Phase 2|
- Determine the efficacy of erlotinib, in terms of response rate and duration of stable disease, in patients with locally advanced and/or metastatic carcinoma of the endometrium.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression and duration of response in patients treated with this drug.
- Correlate objective tumor response with levels of epidermal growth factor receptor expression in patients treated with this drug.
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030485
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Kingston Regional Cancer Centre|
|Kingston, Ontario, Canada, K7L 5P9|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Hopital Notre- Dame du CHUM|
|Montreal, Quebec, Canada, H4L 2M1|
|Study Chair:||Amit M. Oza, MD||Princess Margaret Hospital, Canada|