Trials / Completed
CompletedNCT00026260
SU5416 in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation of SU5416 (NSC 696819) in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | semaxanib |
Timeline
- Completion
- 2003-10-01
- First posted
- 2003-10-21
- Last updated
- 2013-06-24
Source: ClinicalTrials.gov record NCT00026260. Inclusion in this directory is not an endorsement.