Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
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 docetaxel in treating patients who have persistent or recurrent cervical cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix|
- Response rate by GOG RECIST criteria every 8 weeks [ Designated as safety issue: No ]
- Frequency and severity of adverse events by NCI CTC v2.0 every 4 weeks [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Duration of progression-free interval [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of docetaxel in patients with persistent or recurrent squamous cell carcinoma of the cervix.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 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 at least 6-7 months.