SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00026260|
Recruitment Status : Completed
First Posted : October 21, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: semaxanib||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix|
|Actual Study Completion Date :||October 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): NCT00026260
|Study Chair:||Robert A. Burger, MD||Chao Family Comprehensive Cancer Center|