DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
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|ClinicalTrials.gov Identifier: NCT00004866|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 16, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating women who have advanced or recurrent cancer of the cervix.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: exatecan mesylate||Phase 2|
- Determine the antitumor activity of DX-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix.
- Evaluate the quantitative and qualitative toxic effects of this regimen in these patients.
- Evaluate the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced or Recurrent Squamous Cell Cancer of the Cervix|
|Study Start Date :||January 2000|
|Primary Completion Date :||September 2003|
|Study Completion Date :||September 2003|
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): NCT00004866
|United States, New York|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|St. Luke's-Roosevelt Hospital|
|New York, New York, United States, 10019|
|United States, Ohio|
|Ruppert Health Center|
|Toledo, Ohio, United States, 43614|
|United States, Tennessee|
|Brookview Research, Inc.|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Texas Oncology PA (TOPA) at Baylor-Sammons|
|Dallas, Texas, United States, 75246|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Sankyo, Inc.|