Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Weekly Topotecan Hydrochloride (Hycamtin®, NSC #609699) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix|
- Antitumor activity [ Time Frame: every 21 days during treatment for up to 5 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: every 21 days during treatment for up to 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2005|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix that failed higher priority treatment protocols.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patient are followed for every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087126
Show 27 Study Locations
|Study Chair:||James V. Fiorica, MD||Sarasota Memorial Hospital|