SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
RATIONALE: Biological therapy with drugs such as SU5416 may stop the growth of cervical cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have persistent or recurrent cervical cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix|
|Study Completion Date:||October 2003|
- Determine the antitumor cytostatic activity of SU5416, in terms of 6-month progression-free survival and time to progression, in patients with persistent or recurrent cervical squamous cell carcinoma.
- Determine the nature and degree of toxicity of this drug in these patients.
- Correlate surrogate endpoint molecular and imaging markers with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 1 hour on days 1 and 4. Treatment repeats weekly 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: Approximately 19-51 patients will be accrued for this study within 8-23 months.
|Study Chair:||Robert A. Burger, MD||Chao Family Comprehensive Cancer Center|