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Brief Title: SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
Official Title: A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
Study ID: NCT00026260
Brief Summary: 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.
Detailed Description: OBJECTIVES: * 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Name: Robert A. Burger, MD
Affiliation: Chao Family Comprehensive Cancer Center
Role: STUDY_CHAIR